Back to resultsIdentification and Characterization of Bacteria in the Lungs of Children From 6 Months up to 6 Years Old, With Suspected Infection of the Lungs, in Spain.
Primary Purpose
Infections, Streptococcal
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
BAL fluid sampling
Nasopharyngeal swab sampling
Sponsored by
About this trial
This is an interventional other trial for Infections, Streptococcal focused on measuring Chronic lower respiratory tract infection, Bonchoalveolar lavage, Nasopharyngeal swabs
Eligibility Criteria
Inclusion Criteria:
- Subjects who the investigator believes that parent(s)/ legally acceptable representatives (LAR[s]) can and will comply with the requirements of the protocol.
- A male or female subject aged ≥ 6 months to < 6 years at the time of enrolment.
- Subjects meet the case definition of suspected chronic LRTIs where BAL is indicated.
- Subject's parent(s)/ LAR(s) agree to the collection of a nasopharyngeal swab from the subject.
- Written informed consent obtained from the parent(s)/ LAR(s) of the subject.
Exclusion Criteria:
- Known cystic fibrosis, immunosuppression, or other severe immunodeficiencies such as agammaglobu-linaemia, T cell deficiency or Human Immunodeficiency Virus/ Acquired Immune Deficiency Syndrome, chemotherapy treatment, etc.
- Exacerbation of persistent respiratory symptoms (cough, wheezing, difficulty in breathing, etc.) in the previous 2 weeks.
- Antibiotic treatment in the 2 weeks prior to study entry.
- Concurrent participation in another study within 30 days prior to study entry or at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Subjects having previously participated in this study.
- Child in care.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Total group
Arm Description
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
Outcomes
Primary Outcome Measures
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Bacterial aetiology was assessed by culture growth from BAL fluid sample for Steptococcus pneumoniae (S.p.), Haemophilus influenzae (H.i.) and Moraxella catarrhalis (M.c.) , through either qualitative or quantitative bacterial identification (B.I.). The categories assessed were: positive (Pos.), negative (Neg.) and Missing (Mis.). For quantitative bacterial identification, S.p., H.i. and M.c. were confirmed by bacterial identification load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone, or >10^5 cfu/mL if present as co-infection.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples
S. pneumoniae (S.p.), H. influenzae (H.i.) and M. catarrhalis (M.c.) were confirmed by bacterial identification (B.I.) load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone, or >10^5 cfu/mL if presented as co-infection. Analysis was also performed for other bacterial pathogens alone or as co-infection.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses
Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the "Negative M. Catarrhalis" BAL Fluid Samples Results Category)
S. pneumoniae, H. influenzae and M. catarrhalis were confirmed by bacterial identification load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone. Bacterial load referred to Negative M. catarrhalis - Negative S. pneumoniae - Negative H. influenzae (N.M.c.-N.S.p.-N.H.i.), Negative M. catarrhalis - Negative S. pneumoniae - Positive H. influenzae (N.M.c.-N.S.p.-P.H.i.), Negative M. catarrhalis - Positive S. pneumoniae - Negative H. influenzae (N.M.c.-P.S.p.-N.H.i.), Negative M. catarrhalis - Positive S. pneumoniae - Positive H. influenzae (N.M.c.-P.S.p.-P..H.i.).
Notes: bacterial identification for the N.M.c.-P.S.p.-P.H.i. category was confirmed as a co-infection with a bacterial load >10^5 cfu/mL. For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the "Positive M. Catarrhalis" BAL Fluid Samples Results Category)
S. pneumoniae, H. influenzae and M. catarrhalis were confirmed by bacterial identification load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone and by bacterial load >10^5 cfu/mL if presented as co-infection.
Categories referred to Positive M. catarrhalis -Negative S. pneumoniae - Negative H. influenzae (P.M.c.-N.S.p.-N.H.i.), Positive M. catarrhalis -Negative S. pneumoniae - Positive H. influenzae (P.M.c.-N.S.p.-P.H.i.), Positive M. catarrhalis - Positive S. pneumoniae - Negative H. influenzae (P.M.c.-P.S.p.-N.H.i.), Positive M. catarrhalis - Positive S. pneumoniae - Positive H. influenzae (P.M.c.-P.S.p.-P.H.i.). Notes: bacterial identification for the P.M.c.-N.S.p.-P.H.i., P.M.c.-P.S.p.-N.H.i. and P.M.c.-P.S.p.-P.H.i. categories was confirmed by a bacterial identification >10^5 cfu/mL. For one subject who underwent BAL procedure, no BAL fluid was available for study analyses
Secondary Outcome Measures
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Bacterial colonization was assessed by culture growth from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis, through either qualitative or quantitative bacterial identification (B.I.). The categories assessed were: positive (Pos.) and negative (Neg.).
Bacterial Load Detected (log10 Transformation) by Quantitative Culture Growth, From BAL Fluid Samples
Bacterial load was detected by quantitative culture growth from BAL fluid samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/ milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load >10^4 cfu/mL if present alone or > 10^5 cfu/mL if present as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Bacterial Load Detected (log10 Transformation) by Quantitative Molecular Techniques (Polymerase Chain Reaction) From BAL Fluid Samples
Bacterial load was detected by quantitative molecular techniques (PCR) from BAL fluid samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load >10^4 cfu/mL if present alone or > 10^5 cfu/mL if present as co-infection.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture, From BAL Fluid Samples
Bacterial pathogens were detected by qualitative culture from BAL fluid samples and included:
Staphylococcus aureus, Pseudomonas aeruginosa, Stenotrophomonas maltophilia and Pseudomonas putida.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Bacterial Load Detected (log10 Transformation) by Quantitative Culture From Nasopharyngeal Swab Samples
Bacterial load was detected by quantitative culture from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/ milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load >10^4 cfu/mL if present alone or > 10^5 cfu/mL if present as co-infection.
Bacterial Load Detected (log10 Transformation) by Molecular Techniques (PCR) From Nasopharyngeal Swab Samples
Bacterial load was detected by quantitative molecular techniques from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load >10^4 cfu/mL if present alone or > 10^5 cfu/mL if present as co-infection.
Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture From Nasopharyngeal Swab Samples
Bacterial pathogens were detected by qualitative culture from nasopharyngeal swab samples and included: Staphylococcus aureus and Stenotrophomonas maltophilia
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
Two isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. S.p. serogoups and serotypes isolates included: 3, 6B, 7C, 10A, 11A, 11D, 12F, 14, 15B, 16F, 18C, 18F, 19A, 19F, 21, 22F, 23A, 23B, 31, 35F, 42, 48, NT (not typeable), Synflorix serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Pneumococcal conjugate vaccine (PCV) 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). Note: For one subject who underwent BAL procedure, no BALF was available for study analyses.
Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From BAL Fluid Samples
The H. influenzae typing results included "f" and "NT" (not typeable). Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BALF was available for study analyses.
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
S. pneumoniae serogoups and serotypes included: 3, 6A, 6B, 7C, 9N, 10A, 11A, 11D, 12B, 12F, 14, 16F, 18C, 18F, 19A, 19C, 19F, 21, 23A, 23B, 31, 35A, 35F, 42, 48, NT (not typeable), Synflorix serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Pneumococcal conjugate vaccine (PCV) 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F).
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From Nasopharyngeal Swab Samples
The H. influenzae typing results include "f " and "NT" (not typeable). Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Antibiotic response of S.pneumoniae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Penicilin, Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
For the "Unique isolate definition", please refer to the previous outcome description.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Antibiotic response of H.ifluenzae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
For the "Unique isolate definition", please refer to the previous outcomes description.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Descriptive Statistics of the Antimicrobial Susceptibility Response of H. Influenzae for Unique Isolates Among Qualitative Positive Subjects, for Penicilin and Erythromycin
Antibiotic response of H. influenzae was tested against antibiotics which included: Penicilin and Erythromycin (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Antibiotic response of M. catarrhalis was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
For the "Unique isolate definition", please refer to the previous outcome description.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Qualitative Positive Subjects, for Penicilin
Antibiotic response of M. catarrhalis was tested against antibiotics which included: Penicilin.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Number of H. Influenzae or M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response Among Qualitative Positive Siubjects for Beta-lactamase
Antimicrobial response of H. influenzae and M. catarrhalis was tested for Beta-lactamase (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Antibiotic response of S.pneumoniae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Penicilin, Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
For the "Unique isolate definition", please refer to the previous outcome description.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Antibiotic response of H.ifluenzae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015])towards the tested antibiotics which included: Amoxicillin/Clavulanate, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
For the "Unique isolate definition", please refer to the previous outcomes description.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Descriptive Statistics of the Antimicrobial Susceptibility Response of H.Influenzae for Unique Isolates Among Quantitative Positive Subjects, for Penicilin and Erythromycin
Antibiotic response of H.ifluenzae was tested against antibiotics which included: Penicilin and Erythromycin (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Antibiotic response of M. catarrhalis was susceptible (Sus.), or intermediate (Int.), or resistant (Res.)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
For the "Unique isolate definition", please refer to the previous outcome description.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Quantitative Positive Subjects, for Penicilin
Antibiotic response of M. catarrhalis was tested against antibiotics which included: Penicilin (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Number of H. Influenzae and M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response From Quantitative Positive Subjects, for Beta-lactamase
Antimicrobial response of H. influenzae and M. catarrhalis was tested for Beta-lactamase (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Mean Age of Subjects
Demographic characteristics included age, which was expressed in months.
Subject Gender
Demographic characteristics included gender: female and male.
Mean Weight of Subjects
Demographic characteristics included weight which was expressed in kilograms (kg).
Mean Height of Subjects
Demographic characteristics included height which was expressed in centimeters (cm).
Number of Subjects With Body Mass Index (BMI) Characteristics
Demographic characteristics included body mass index (BMI) whose z-scores were measures of relative weight adjusted for child age and sex.
Number of Subjects Presenting General Medical History Characteristics
General medical history characteristics included: any pre-existing conditions, congenital chromosomal abnormality, prematurity (less than 37 weeks) neonatal problems, chronic renal failure, immune system disorder (including auto-immune), atopic dermatitis, clinician-confirmed eczema, asthma and other.
Mean Gestational Age of Subjects
General medical history included mean gestational age.
Number of Subjects With Pneumococcal Vaccination History Characteristics
Pneumococcal vaccination history characteristics included vaccination, pneumococcal vaccines received (Prevnar only, Prevnar 13 only, Synflorix only, Mix of vaccines), Prevnar only doses (1-4), Prevnar 13 only doses (1-4), Synflorix only doses (4), medical history source validated or not.
Number of Subjects With Flu Vaccination History Characteristics
Flu vaccination history included vaccination, Flu vaccine doses (1-5), medical history source validated or not.
Number of Subjects With Haemophilus Influenzae Type b Vaccination History Characteristics
Haemophilus influenzae type b vaccination history included vaccination, Haemophilus influenzae type b vaccine doses (1-4), medical history source validated or not.
Number of Subjects With Antibiotics and Other Medications Administered
Medication history referred to antibiotics administered in the past 6 months, drug names, antibiotic information source, other medications administered during the past 6 months, information source.
Number of Subjects With Clinical Characteristics
Clinical characteristics included affections/pre-conditions, affection episodes, number of children living in a household, children in day-care centres, exposure to cigarette smoke.
Number of Subjects With Laboratory Results
Laboratory results included blood sample results available, white blood Cell (WBC) count analysed, WBC reference range, Clinically relevant to the suspected chronic lower respiratory tract infection (LRTI) in the child if out of the range of WBC [LRTI-WBC], CRP (C-reactive protein) reference range, CRP groups, Clinically relevant to the suspected chronic LRTI in the child if out of the range of CRP [LRTI-CRP], ESR (Erythrocyte sedimentation rate) analysed, ESR reference range and Clinically relevant to the suspected chronic LRTI in the child if out of the range of ESR [LRTI-ESR].
White Blood Cells (WBC) Laboratory Results
Laboratory results for WBC were expressed in 10^9 cells per liter (10^9 cells/L).
C-reactive Protein (CRP) Laboratory Results
Laboratory results for CRP were expressed in milligrams per litre (mg/L).
Erythrocyte Sedimentation Rate (ESR) Laboratory Results
Laboratory results for ESR were expressed in millimeters per hour (mm/hr).
Number of Subjects With Radiological Results
Radiological results included x-ray, result normality, relationship of abnormality to BAL sampling.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02838407
Brief Title
Identification and Characterization of Bacteria in the Lungs of Children From 6 Months up to 6 Years Old, With Suspected Infection of the Lungs, in Spain.
Official Title
Identification and Characterization of Bacteria in the Lower Airways of Children Aged ≥ 6 Months to < 6 Years With Suspected Lower Respiratory Tract Infections (LRTI) in Spain.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 23, 2013 (Actual)
Primary Completion Date
September 23, 2015 (Actual)
Study Completion Date
September 23, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to identify and characterise bacteria present in the lower airways of children with suspected chronic LRTIs and for whom bronchoalveolar lavage (BAL) is indicated by the clinician.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Streptococcal
Keywords
Chronic lower respiratory tract infection, Bonchoalveolar lavage, Nasopharyngeal swabs
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
197 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Total group
Arm Type
Other
Arm Description
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
Intervention Type
Other
Intervention Name(s)
BAL fluid sampling
Intervention Description
Following routine BAL procedures at the hospital, collection of BAL fluid samples: at least 2 mL, at Day 0.
Intervention Type
Other
Intervention Name(s)
Nasopharyngeal swab sampling
Intervention Description
1 swab, Day 0
Primary Outcome Measure Information:
Title
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Description
Bacterial aetiology was assessed by culture growth from BAL fluid sample for Steptococcus pneumoniae (S.p.), Haemophilus influenzae (H.i.) and Moraxella catarrhalis (M.c.) , through either qualitative or quantitative bacterial identification (B.I.). The categories assessed were: positive (Pos.), negative (Neg.) and Missing (Mis.). For quantitative bacterial identification, S.p., H.i. and M.c. were confirmed by bacterial identification load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone, or >10^5 cfu/mL if present as co-infection.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time Frame
From Day 0 up to Year 2
Title
Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples
Description
S. pneumoniae (S.p.), H. influenzae (H.i.) and M. catarrhalis (M.c.) were confirmed by bacterial identification (B.I.) load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone, or >10^5 cfu/mL if presented as co-infection. Analysis was also performed for other bacterial pathogens alone or as co-infection.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses
Time Frame
From Day 0 up to Year 2
Title
Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the "Negative M. Catarrhalis" BAL Fluid Samples Results Category)
Description
S. pneumoniae, H. influenzae and M. catarrhalis were confirmed by bacterial identification load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone. Bacterial load referred to Negative M. catarrhalis - Negative S. pneumoniae - Negative H. influenzae (N.M.c.-N.S.p.-N.H.i.), Negative M. catarrhalis - Negative S. pneumoniae - Positive H. influenzae (N.M.c.-N.S.p.-P.H.i.), Negative M. catarrhalis - Positive S. pneumoniae - Negative H. influenzae (N.M.c.-P.S.p.-N.H.i.), Negative M. catarrhalis - Positive S. pneumoniae - Positive H. influenzae (N.M.c.-P.S.p.-P..H.i.).
Notes: bacterial identification for the N.M.c.-P.S.p.-P.H.i. category was confirmed as a co-infection with a bacterial load >10^5 cfu/mL. For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time Frame
From Day 0 up to Year 2
Title
Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the "Positive M. Catarrhalis" BAL Fluid Samples Results Category)
Description
S. pneumoniae, H. influenzae and M. catarrhalis were confirmed by bacterial identification load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone and by bacterial load >10^5 cfu/mL if presented as co-infection.
Categories referred to Positive M. catarrhalis -Negative S. pneumoniae - Negative H. influenzae (P.M.c.-N.S.p.-N.H.i.), Positive M. catarrhalis -Negative S. pneumoniae - Positive H. influenzae (P.M.c.-N.S.p.-P.H.i.), Positive M. catarrhalis - Positive S. pneumoniae - Negative H. influenzae (P.M.c.-P.S.p.-N.H.i.), Positive M. catarrhalis - Positive S. pneumoniae - Positive H. influenzae (P.M.c.-P.S.p.-P.H.i.). Notes: bacterial identification for the P.M.c.-N.S.p.-P.H.i., P.M.c.-P.S.p.-N.H.i. and P.M.c.-P.S.p.-P.H.i. categories was confirmed by a bacterial identification >10^5 cfu/mL. For one subject who underwent BAL procedure, no BAL fluid was available for study analyses
Time Frame
From Day 0 up to Year 2
Secondary Outcome Measure Information:
Title
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Description
Bacterial colonization was assessed by culture growth from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis, through either qualitative or quantitative bacterial identification (B.I.). The categories assessed were: positive (Pos.) and negative (Neg.).
Time Frame
From Day 0 up to Year 2
Title
Bacterial Load Detected (log10 Transformation) by Quantitative Culture Growth, From BAL Fluid Samples
Description
Bacterial load was detected by quantitative culture growth from BAL fluid samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/ milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load >10^4 cfu/mL if present alone or > 10^5 cfu/mL if present as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time Frame
From Day 0 up to Year 2
Title
Bacterial Load Detected (log10 Transformation) by Quantitative Molecular Techniques (Polymerase Chain Reaction) From BAL Fluid Samples
Description
Bacterial load was detected by quantitative molecular techniques (PCR) from BAL fluid samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load >10^4 cfu/mL if present alone or > 10^5 cfu/mL if present as co-infection.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time Frame
From Day 0 up to Year 2
Title
Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture, From BAL Fluid Samples
Description
Bacterial pathogens were detected by qualitative culture from BAL fluid samples and included:
Staphylococcus aureus, Pseudomonas aeruginosa, Stenotrophomonas maltophilia and Pseudomonas putida.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time Frame
From Day 0 up to Year 2
Title
Bacterial Load Detected (log10 Transformation) by Quantitative Culture From Nasopharyngeal Swab Samples
Description
Bacterial load was detected by quantitative culture from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/ milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load >10^4 cfu/mL if present alone or > 10^5 cfu/mL if present as co-infection.
Time Frame
From Day 0 up to Year 2
Title
Bacterial Load Detected (log10 Transformation) by Molecular Techniques (PCR) From Nasopharyngeal Swab Samples
Description
Bacterial load was detected by quantitative molecular techniques from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load >10^4 cfu/mL if present alone or > 10^5 cfu/mL if present as co-infection.
Time Frame
From Day 0 and up to Year 2
Title
Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture From Nasopharyngeal Swab Samples
Description
Bacterial pathogens were detected by qualitative culture from nasopharyngeal swab samples and included: Staphylococcus aureus and Stenotrophomonas maltophilia
Time Frame
From Day 0 and up to Year 2
Title
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
Description
Two isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. S.p. serogoups and serotypes isolates included: 3, 6B, 7C, 10A, 11A, 11D, 12F, 14, 15B, 16F, 18C, 18F, 19A, 19F, 21, 22F, 23A, 23B, 31, 35F, 42, 48, NT (not typeable), Synflorix serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Pneumococcal conjugate vaccine (PCV) 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). Note: For one subject who underwent BAL procedure, no BALF was available for study analyses.
Time Frame
From Day 0 to Year 2
Title
Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From BAL Fluid Samples
Description
The H. influenzae typing results included "f" and "NT" (not typeable). Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BALF was available for study analyses.
Time Frame
From Day 0 to Year 2
Title
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
Description
S. pneumoniae serogoups and serotypes included: 3, 6A, 6B, 7C, 9N, 10A, 11A, 11D, 12B, 12F, 14, 16F, 18C, 18F, 19A, 19C, 19F, 21, 23A, 23B, 31, 35A, 35F, 42, 48, NT (not typeable), Synflorix serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Pneumococcal conjugate vaccine (PCV) 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F).
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Time Frame
From Day 0 to Year 2
Title
Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From Nasopharyngeal Swab Samples
Description
The H. influenzae typing results include "f " and "NT" (not typeable). Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Time Frame
From Day 0 to Year 2
Title
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Description
Antibiotic response of S.pneumoniae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Penicilin, Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
For the "Unique isolate definition", please refer to the previous outcome description.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time Frame
From Day 0 to Year 2
Title
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Description
Antibiotic response of H.ifluenzae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
For the "Unique isolate definition", please refer to the previous outcomes description.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time Frame
From Day 0 to Year 2
Title
Descriptive Statistics of the Antimicrobial Susceptibility Response of H. Influenzae for Unique Isolates Among Qualitative Positive Subjects, for Penicilin and Erythromycin
Description
Antibiotic response of H. influenzae was tested against antibiotics which included: Penicilin and Erythromycin (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time Frame
From Day 0 to Year 2
Title
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Description
Antibiotic response of M. catarrhalis was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
For the "Unique isolate definition", please refer to the previous outcome description.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time Frame
From Day 0 to Year 2
Title
Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Qualitative Positive Subjects, for Penicilin
Description
Antibiotic response of M. catarrhalis was tested against antibiotics which included: Penicilin.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time Frame
From Day 0 to Year 2
Title
Number of H. Influenzae or M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response Among Qualitative Positive Siubjects for Beta-lactamase
Description
Antimicrobial response of H. influenzae and M. catarrhalis was tested for Beta-lactamase (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time Frame
From Day 0 to Year 2
Title
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Description
Antibiotic response of S.pneumoniae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Penicilin, Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
For the "Unique isolate definition", please refer to the previous outcome description.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time Frame
From Day 0 to Year 2
Title
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Description
Antibiotic response of H.ifluenzae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015])towards the tested antibiotics which included: Amoxicillin/Clavulanate, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
For the "Unique isolate definition", please refer to the previous outcomes description.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time Frame
From Day 0 to Year 2
Title
Descriptive Statistics of the Antimicrobial Susceptibility Response of H.Influenzae for Unique Isolates Among Quantitative Positive Subjects, for Penicilin and Erythromycin
Description
Antibiotic response of H.ifluenzae was tested against antibiotics which included: Penicilin and Erythromycin (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time Frame
From Day 0 to Year 2
Title
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Description
Antibiotic response of M. catarrhalis was susceptible (Sus.), or intermediate (Int.), or resistant (Res.)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
For the "Unique isolate definition", please refer to the previous outcome description.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time Frame
From Day 0 to Year 2
Title
Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Quantitative Positive Subjects, for Penicilin
Description
Antibiotic response of M. catarrhalis was tested against antibiotics which included: Penicilin (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time Frame
From Day 0 to Year 2
Title
Number of H. Influenzae and M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response From Quantitative Positive Subjects, for Beta-lactamase
Description
Antimicrobial response of H. influenzae and M. catarrhalis was tested for Beta-lactamase (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time Frame
From Day 0 to Year 2
Title
Mean Age of Subjects
Description
Demographic characteristics included age, which was expressed in months.
Time Frame
From Day 0 to Year 2
Title
Subject Gender
Description
Demographic characteristics included gender: female and male.
Time Frame
From Day 0 to Year 2
Title
Mean Weight of Subjects
Description
Demographic characteristics included weight which was expressed in kilograms (kg).
Time Frame
From Day 0 to Year 2
Title
Mean Height of Subjects
Description
Demographic characteristics included height which was expressed in centimeters (cm).
Time Frame
From Day 0 to Year 2
Title
Number of Subjects With Body Mass Index (BMI) Characteristics
Description
Demographic characteristics included body mass index (BMI) whose z-scores were measures of relative weight adjusted for child age and sex.
Time Frame
From Day 0 to Year 2
Title
Number of Subjects Presenting General Medical History Characteristics
Description
General medical history characteristics included: any pre-existing conditions, congenital chromosomal abnormality, prematurity (less than 37 weeks) neonatal problems, chronic renal failure, immune system disorder (including auto-immune), atopic dermatitis, clinician-confirmed eczema, asthma and other.
Time Frame
From Day 0 to Year 2
Title
Mean Gestational Age of Subjects
Description
General medical history included mean gestational age.
Time Frame
From Day 0 to Year 2
Title
Number of Subjects With Pneumococcal Vaccination History Characteristics
Description
Pneumococcal vaccination history characteristics included vaccination, pneumococcal vaccines received (Prevnar only, Prevnar 13 only, Synflorix only, Mix of vaccines), Prevnar only doses (1-4), Prevnar 13 only doses (1-4), Synflorix only doses (4), medical history source validated or not.
Time Frame
From Day 0 to Year 2
Title
Number of Subjects With Flu Vaccination History Characteristics
Description
Flu vaccination history included vaccination, Flu vaccine doses (1-5), medical history source validated or not.
Time Frame
From Day 0 to Year 2
Title
Number of Subjects With Haemophilus Influenzae Type b Vaccination History Characteristics
Description
Haemophilus influenzae type b vaccination history included vaccination, Haemophilus influenzae type b vaccine doses (1-4), medical history source validated or not.
Time Frame
From Day 0 to Year 2
Title
Number of Subjects With Antibiotics and Other Medications Administered
Description
Medication history referred to antibiotics administered in the past 6 months, drug names, antibiotic information source, other medications administered during the past 6 months, information source.
Time Frame
From Day 0 to Year 2
Title
Number of Subjects With Clinical Characteristics
Description
Clinical characteristics included affections/pre-conditions, affection episodes, number of children living in a household, children in day-care centres, exposure to cigarette smoke.
Time Frame
From Day 0 to Year 2
Title
Number of Subjects With Laboratory Results
Description
Laboratory results included blood sample results available, white blood Cell (WBC) count analysed, WBC reference range, Clinically relevant to the suspected chronic lower respiratory tract infection (LRTI) in the child if out of the range of WBC [LRTI-WBC], CRP (C-reactive protein) reference range, CRP groups, Clinically relevant to the suspected chronic LRTI in the child if out of the range of CRP [LRTI-CRP], ESR (Erythrocyte sedimentation rate) analysed, ESR reference range and Clinically relevant to the suspected chronic LRTI in the child if out of the range of ESR [LRTI-ESR].
Time Frame
From Day 0 to Year 2
Title
White Blood Cells (WBC) Laboratory Results
Description
Laboratory results for WBC were expressed in 10^9 cells per liter (10^9 cells/L).
Time Frame
From Day 0 to Year 2
Title
C-reactive Protein (CRP) Laboratory Results
Description
Laboratory results for CRP were expressed in milligrams per litre (mg/L).
Time Frame
From Day 0 to Year 2
Title
Erythrocyte Sedimentation Rate (ESR) Laboratory Results
Description
Laboratory results for ESR were expressed in millimeters per hour (mm/hr).
Time Frame
From Day 0 to Year 2
Title
Number of Subjects With Radiological Results
Description
Radiological results included x-ray, result normality, relationship of abnormality to BAL sampling.
Time Frame
From Day 0 to Year 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes that parent(s)/ legally acceptable representatives (LAR[s]) can and will comply with the requirements of the protocol.
A male or female subject aged ≥ 6 months to < 6 years at the time of enrolment.
Subjects meet the case definition of suspected chronic LRTIs where BAL is indicated.
Subject's parent(s)/ LAR(s) agree to the collection of a nasopharyngeal swab from the subject.
Written informed consent obtained from the parent(s)/ LAR(s) of the subject.
Exclusion Criteria:
Known cystic fibrosis, immunosuppression, or other severe immunodeficiencies such as agammaglobu-linaemia, T cell deficiency or Human Immunodeficiency Virus/ Acquired Immune Deficiency Syndrome, chemotherapy treatment, etc.
Exacerbation of persistent respiratory symptoms (cough, wheezing, difficulty in breathing, etc.) in the previous 2 weeks.
Antibiotic treatment in the 2 weeks prior to study entry.
Concurrent participation in another study within 30 days prior to study entry or at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Subjects having previously participated in this study.
Child in care.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Barakaldo (Vizcaya)
ZIP/Postal Code
48903
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
GSK Investigational Site
City
Murcia (El Palmar)
ZIP/Postal Code
30120
Country
Spain
Facility Name
GSK Investigational Site
City
Sabadell (Barcelona)
ZIP/Postal Code
08208
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29285648
Citation
Escribano Montaner A, Garcia de Lomas J, Villa Asensi JR, Asensio de la Cruz O, de la Serna Blazquez O, Santiago Burruchaga M, Mondejar Lopez P, Torrent Vernetta A, Feng Y, Van Dyke MK, Reyes J, Garcia-Corbeira P, Talarico CA; EPI-Strep-064 study group. Bacteria from bronchoalveolar lavage fluid from children with suspected chronic lower respiratory tract infection: results from a multi-center, cross-sectional study in Spain. Eur J Pediatr. 2018 Feb;177(2):181-192. doi: 10.1007/s00431-017-3044-3. Epub 2017 Dec 29.
Results Reference
background
Learn more about this trial
Identification and Characterization of Bacteria in the Lungs of Children From 6 Months up to 6 Years Old, With Suspected Infection of the Lungs, in Spain.
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