A Pharmacokinetics and Safety Study of Augmentin ES-600 in Children With CAP and ABRS
Primary Purpose
Infections, Bacterial
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Augmentin ES
Sponsored by
About this trial
This is an interventional treatment trial for Infections, Bacterial focused on measuring Amoxicillin, Clavulanic acid, Community Acquired Pneumonia, Acute Bacterial Rhinosinusitis, Pharmacokinetics, Safety, Clinical response, Augmentin ES
Eligibility Criteria
Inclusion Criteria:
- The participant and/or parent(s)/legal guardian(s) are willing and able to comply with the study protocol.
- In accordance with regional/local laws and regulations,
- a. the parent(s)/legal guardian(s) has given signed informed, dated consent; and the participant has
- b.given written assent, if applicable, to participate in the study (for participants between 7 to 12 years)
- Age: Participant must be aged greater than or equal to (>=) 3 months to 12 years, of either gender.
- Participants who are otherwise healthy and presenting with suspected CAP.
- For participants clinically suspected of CAP, at least 3 of the following 4 criteria are applicable:
- a) History of productive cough and/or shortness of breath.
- b)Fever greater than (>)38.5 degree Celsius (○C) (Axillary temperature)
- c) Tachypnea as defined by Respiratory rate (RR) >= 50 breaths/minute in children up to 11 months RR >= 40 breaths/minute in children from 12 months onwards
- d) Chest X-Ray with shadow or lobar condensation, unilateral or bilateral.
For participants of ABRS:
- The participant and/or parent(s)/legal guardian(s) are willing and able to comply with the study protocol.
- In accordance with regional/local laws and regulations,
- a..The parent(s)/legal guardian(s) has given signed informed, dated consent; and the participant has
- b. given written assent, if applicable, to participate in the study (for participants between 7 to 12 years).
- Age: Participant must be between >=3 months to 12 years of either gender.
- Participants who are otherwise healthy and presenting with suspected ABRS.
- For participants of clinically suspected ABRS, the participants would be eligible if any of the following 2 of the 3 criteria stated below are met:
- a.Children with purulent nasal discharge or daytime productive cough (which may worsen at night) or both persisting for 10 days or more without evidence of improvement.
- b. Fever > 38.3○C (Axillary temperature)
- c. Double sickness defined as initial improvement of symptoms and further worsening/ deterioration after 5 days.
Exclusion Criteria:
- Severe ABRS/CAP requiring hospitalization.
- Currently receiving or has received more than one dose of systemic antibiotic therapy within one week prior to the initiation of the study.
- A serious underlying disease as per clinician's judgment.
- Human immunodeficiency virus (HIV) infection/or any other immunosuppressive condition
- Pre-existing renal insufficiency (for example [e.g.], plasma creatinine > 1.5 times upper limit of normal range for age).
- Pre-existing liver disease(s) and/or hepatic dysfunction.
- Any pre-existing malignancy/any participants undergoing any kind of chemotherapy.
- Evidence of leukopenia and/or thrombocytopenia.
- History of previous hypersensitivity reaction to penicillins, cephalosporins or other Beta-lactam antibiotics.
- History of amoxicillin-clavulanate associated cholestatic jaundice/hepatic dysfunction.
- History of phenylketonuria or a known hypersensitivity to aspartame.
- Received, within 48 hours of study entry, or is scheduled to receive during the study period, any medication which may alter bowel function.
- Received, within 48 hours of study entry, or is scheduled to receive during the study period, any medication which may alter renal function like probenecid.
- Participants who have chronic sinusitis (signs and symptoms lasting greater than 28 days prior to screening visit.
- Significant abnormalities of the sinuses and any complications of ABRS.
- Have concurrent streptococcal pharyngitis or acute otitis media (as the standard doses for both of these conditions is 10 days).
- Any other infection or condition, which necessitates use of a concomitant systemic antimicrobial.
- History of infectious mononucleosis.
- History of pseudomembranous colitis.
- Participants that are on warfarin therapy.
- Receipt of an investigational compound (non-food and drug administration [FDA] and non-Brazil National Health Surveillance Agency [ANVISA] approved) or device within the previous 30 days or five half-lives, whichever is longer, preceding the first dose of study intervention or during the study.
- Participants with symptoms suggestive of active Coronavirus disease 2019 (COVID-19) infection (that is (i.e.), fever, cough, etc.)
- Participants with known COVID-19 positive contacts within the past 14 days.
- Female participants who have attained menarche
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants with CAP and ABRS
Arm Description
Outcomes
Primary Outcome Measures
Absorption rate constant (Ka) of amoxicillin and clavulanic acid combination
Area under the serum concentration-time curve (AUC) of amoxicillin and clavulanic acid combination
Maximum serum concentration (Cmax) of amoxicillin and clavulanic acid combination
Clearance (CL) of amoxicillin and clavulanic acid combination
Volume of distribution (Vd) of amoxicillin and clavulanic acid combination
Terminal half-life (t1/2) of amoxicillin and clavulanic acid combination
Secondary Outcome Measures
Number of participants with treatment emergent adverse events (TEAE)
Number of participants achieving Primary Clinical Response
Number of participants achieving Secondary Clinical response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05340257
Brief Title
A Pharmacokinetics and Safety Study of Augmentin ES-600 in Children With CAP and ABRS
Official Title
An Open Label, Single Arm Study, to Evaluate the Pharmacokinetics and Safety of Augmentin Extra Strength (ES)-600 Suspension in Children Presenting With Community Acquired Pneumonia (CAP) and Acute Bacterial Rhinosinusitis (ABRS) in Brazil
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 23, 2023 (Anticipated)
Primary Completion Date
January 17, 2024 (Anticipated)
Study Completion Date
January 17, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics, safety or tolerability through treatment emergent adverse event (TEAE) and to explore primary and secondary clinical response of treatment with Augmentin ES in pediatric population presenting with CAP and ABRS in Brazil.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Bacterial
Keywords
Amoxicillin, Clavulanic acid, Community Acquired Pneumonia, Acute Bacterial Rhinosinusitis, Pharmacokinetics, Safety, Clinical response, Augmentin ES
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
This is a single arm study
Masking
None (Open Label)
Masking Description
This is an open-label study
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants with CAP and ABRS
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Augmentin ES
Intervention Description
Amoxicillin and clavulanic acid in fixed dose combination will be administered
Primary Outcome Measure Information:
Title
Absorption rate constant (Ka) of amoxicillin and clavulanic acid combination
Time Frame
Up to 10 days
Title
Area under the serum concentration-time curve (AUC) of amoxicillin and clavulanic acid combination
Time Frame
Up to 10 days
Title
Maximum serum concentration (Cmax) of amoxicillin and clavulanic acid combination
Time Frame
Up to 10 days
Title
Clearance (CL) of amoxicillin and clavulanic acid combination
Time Frame
Up to 10 days
Title
Volume of distribution (Vd) of amoxicillin and clavulanic acid combination
Time Frame
Up to 10 days
Title
Terminal half-life (t1/2) of amoxicillin and clavulanic acid combination
Time Frame
Up to 10 days
Secondary Outcome Measure Information:
Title
Number of participants with treatment emergent adverse events (TEAE)
Time Frame
Up to Day 14
Title
Number of participants achieving Primary Clinical Response
Time Frame
Day 11 to Day 14
Title
Number of participants achieving Secondary Clinical response
Time Frame
Day 22 to Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The participant and/or parent(s)/legal guardian(s) are willing and able to comply with the study protocol.
In accordance with regional/local laws and regulations,
a. the parent(s)/legal guardian(s) has given signed informed, dated consent; and the participant has
b.given written assent, if applicable, to participate in the study (for participants between 7 to 12 years)
Age: Participant must be aged greater than or equal to (>=) 3 months to 12 years, of either gender.
Participants who are otherwise healthy and presenting with suspected CAP.
For participants clinically suspected of CAP, at least 3 of the following 4 criteria are applicable:
a) History of productive cough and/or shortness of breath.
b)Fever greater than (>)38.5 degree Celsius (○C) (Axillary temperature)
c) Tachypnea as defined by Respiratory rate (RR) >= 50 breaths/minute in children up to 11 months RR >= 40 breaths/minute in children from 12 months onwards
d) Chest X-Ray with shadow or lobar condensation, unilateral or bilateral.
For participants of ABRS:
The participant and/or parent(s)/legal guardian(s) are willing and able to comply with the study protocol.
In accordance with regional/local laws and regulations,
a..The parent(s)/legal guardian(s) has given signed informed, dated consent; and the participant has
b. given written assent, if applicable, to participate in the study (for participants between 7 to 12 years).
Age: Participant must be between >=3 months to 12 years of either gender.
Participants who are otherwise healthy and presenting with suspected ABRS.
For participants of clinically suspected ABRS, the participants would be eligible if any of the following 2 of the 3 criteria stated below are met:
a.Children with purulent nasal discharge or daytime productive cough (which may worsen at night) or both persisting for 10 days or more without evidence of improvement.
b. Fever > 38.3○C (Axillary temperature)
c. Double sickness defined as initial improvement of symptoms and further worsening/ deterioration after 5 days.
Exclusion Criteria:
Severe ABRS/CAP requiring hospitalization.
Currently receiving or has received more than one dose of systemic antibiotic therapy within one week prior to the initiation of the study.
A serious underlying disease as per clinician's judgment.
Human immunodeficiency virus (HIV) infection/or any other immunosuppressive condition
Pre-existing renal insufficiency (for example [e.g.], plasma creatinine > 1.5 times upper limit of normal range for age).
Pre-existing liver disease(s) and/or hepatic dysfunction.
Any pre-existing malignancy/any participants undergoing any kind of chemotherapy.
Evidence of leukopenia and/or thrombocytopenia.
History of previous hypersensitivity reaction to penicillins, cephalosporins or other Beta-lactam antibiotics.
History of amoxicillin-clavulanate associated cholestatic jaundice/hepatic dysfunction.
History of phenylketonuria or a known hypersensitivity to aspartame.
Received, within 48 hours of study entry, or is scheduled to receive during the study period, any medication which may alter bowel function.
Received, within 48 hours of study entry, or is scheduled to receive during the study period, any medication which may alter renal function like probenecid.
Participants who have chronic sinusitis (signs and symptoms lasting greater than 28 days prior to screening visit.
Significant abnormalities of the sinuses and any complications of ABRS.
Have concurrent streptococcal pharyngitis or acute otitis media (as the standard doses for both of these conditions is 10 days).
Any other infection or condition, which necessitates use of a concomitant systemic antimicrobial.
History of infectious mononucleosis.
History of pseudomembranous colitis.
Participants that are on warfarin therapy.
Receipt of an investigational compound (non-food and drug administration [FDA] and non-Brazil National Health Surveillance Agency [ANVISA] approved) or device within the previous 30 days or five half-lives, whichever is longer, preceding the first dose of study intervention or during the study.
Participants with symptoms suggestive of active Coronavirus disease 2019 (COVID-19) infection (that is (i.e.), fever, cough, etc.)
Participants with known COVID-19 positive contacts within the past 14 days.
Female participants who have attained menarche
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Learn more about this trial
A Pharmacokinetics and Safety Study of Augmentin ES-600 in Children With CAP and ABRS
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