Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France (DREPANO-BACT)
Primary Purpose
Sickle Cell Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nasopharyngeal swabbing
Sponsored by
About this trial
This is an interventional screening trial for Sickle Cell Disease focused on measuring Sickle celle disease, Nasopharyngeal bacterial carriage
Eligibility Criteria
Inclusion Criteria:
- Children aged 6 months to 15 years, regardless of immunization status.
- Child with a major sickle cell syndrome (SS, SC, S+, S°, SE) followed in one of the centers of competence or reference for rare diseases (CRMR) " Major sickle cell syndromes, Thalassemias and other rare pathologies of the Red Blood Cell and Erythropoiesis " in Ile de France.
- Children who are not subject to legal protection measures.
- Child affiliated to a social security system.
- Signed informed consent
Exclusion Criteria:
- Sickle cell child with a febrile syndrome at the time of sampling or hospitalized for any reason.
- Child having received antibiotic therapy other than oracillin in the 7 days preceding the nasopharyngeal swab.
- Child already included in the observation period (only 1 nasopharyngeal swab per patient).
- Other hemoglobinopathies and heterozygous AS or AC patients.
- Patients already involved in a therapeutic protocol or in the exclusion period following a previous research.
- Patients under AME or without social security coverage.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
sickle cell children group
control children group
Arm Description
A nasopharyngeal swab is taken during the consultation, with bacteriological analysis.
healthy children control group (ACTIV network)
Outcomes
Primary Outcome Measures
determine the proportion of sickle cell children with nasopharyngeal carriage of Streptococcus pneumoniae (Sp) among the total number of sickle cell children screened by nasopharyngeal swab.
the rate of nasopharyngeal carriage of Streptococcus pneumoniae (Sp) in children with sickle cell disease aged over 6 months and under 15 years over a 12-month period in Ile-De-France.
Secondary Outcome Measures
determine the rate of nasopharyngeal carriage of penicillin-deficient pneumococcus (PDSP) in sickle cell children over 6 months and under 15 years of age over a 9-month period in Ile-De-France.
Proportion of sickle cell children with nasopharyngeal carriage of penicillin-deficient pneumococcus (PDSP) among the total number of sickle cell children screened by nasopharyngeal swab.
determine the proportion of vaccine serotypes among pneumococcal strains in children with sickle cell disease aged over 6 months and under 15
Proportion of children with vaccine serotypes among the pneumococcal strains
Determine the proportion of non-vaccine serotypes among all pneumococcal strains in children with sickle cell disease over 6 months and under 15 years of age.
Proportion of non-vaccine serotypes among all pneumococcal strains.
Determine the nasopharyngeal carriage rate of methicillin-resistant Staphylococcus aureus (MRSA), Haemophilus influenzae, Moraxella catarrhalis in children with sickle cell disease over 6 months and under 15 years of age.
Proportion of children with MRSA, Haemophilus influenzae, Moraxella Catarrhalis (isolated from a nasopharyngeal swab).
compare the rate of nasopharyngeal carriage of Streptococcus pneumoniae and PSDP between the sickle cell group and the healthy group of children according to age groups.
Proportion of children with Streptococcus pneumoniae and PSDP (isolated on nasopharyngeal swab) by age group.
Compare the proportion of non-vaccine serotypes among the Streptococcus pneumoniae strains between the sickle cell group and the healthy group of children.
Proportion of non-vaccine serotypes among nasopharyngeal strains of Streptococcus pneumoniae.
compare the nasopharyngeal carriage rate of MRSA, Haemophilus influenzae, Moraxella catarrhalis between the sickle cell group and the healthy children group.
Proportion of children with MRSA, Haemophilus influenzae, Moraxella Catarrhalis (isolated on nasopharyngeal swab).
Full Information
NCT ID
NCT05197205
First Posted
December 9, 2021
Last Updated
January 4, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT05197205
Brief Title
Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France
Acronym
DREPANO-BACT
Official Title
Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
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 objective of this study is to to determine the rate of nasopharyngeal carriage of Streptococcus pneumoniae (Sp) in children with sickle cell disease over 6 months and under 15 years of age over a 9-month period in Ile-De-France.
Detailed Description
Sickle cell disease is the most common genetic disease in France, with one affected child for every 1,736 births. Ile-de-France is the region in Europe with the highest prevalence of sickle cell disease.
Children with sickle cell disease have an increased susceptibility to infections related to encapsulated bacteria and are at high risk of invasive infections (particularly Streptococcus pneumoniae), which is the leading cause of mortality in children with sickle cell disease under 5 years of age worldwide.
the patients are subject to intense selection pressure (long-term antibiotic prophylaxis and systematic probabilistic curative antibiotic therapy) and are at high risk of carrying nosocomial bacteria (repeated hospitalizations). Moreover, children with sickle cell disease have reinforced immunization schedules, especially against pneumococcal disease.
However, data concerning the carriage of resistant bacteria (prevalence, risk factors) in children with sickle cell disease in France are scarce.
This study aims to determine the nasopharyngeal bacterial carriage and antibiotic resistance in children with sickle cell disease in Ile-De-France
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
Sickle celle disease, Nasopharyngeal bacterial carriage
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sickle cell children group
Arm Type
Experimental
Arm Description
A nasopharyngeal swab is taken during the consultation, with bacteriological analysis.
Arm Title
control children group
Arm Type
No Intervention
Arm Description
healthy children control group (ACTIV network)
Intervention Type
Procedure
Intervention Name(s)
nasopharyngeal swabbing
Intervention Description
A nasopharyngeal swab is collected during the consultation, with bacteriological analysis. No follow-up visit is required for this study
Primary Outcome Measure Information:
Title
determine the proportion of sickle cell children with nasopharyngeal carriage of Streptococcus pneumoniae (Sp) among the total number of sickle cell children screened by nasopharyngeal swab.
Description
the rate of nasopharyngeal carriage of Streptococcus pneumoniae (Sp) in children with sickle cell disease aged over 6 months and under 15 years over a 12-month period in Ile-De-France.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
determine the rate of nasopharyngeal carriage of penicillin-deficient pneumococcus (PDSP) in sickle cell children over 6 months and under 15 years of age over a 9-month period in Ile-De-France.
Description
Proportion of sickle cell children with nasopharyngeal carriage of penicillin-deficient pneumococcus (PDSP) among the total number of sickle cell children screened by nasopharyngeal swab.
Time Frame
12 months
Title
determine the proportion of vaccine serotypes among pneumococcal strains in children with sickle cell disease aged over 6 months and under 15
Description
Proportion of children with vaccine serotypes among the pneumococcal strains
Time Frame
12 months
Title
Determine the proportion of non-vaccine serotypes among all pneumococcal strains in children with sickle cell disease over 6 months and under 15 years of age.
Description
Proportion of non-vaccine serotypes among all pneumococcal strains.
Time Frame
12 months
Title
Determine the nasopharyngeal carriage rate of methicillin-resistant Staphylococcus aureus (MRSA), Haemophilus influenzae, Moraxella catarrhalis in children with sickle cell disease over 6 months and under 15 years of age.
Description
Proportion of children with MRSA, Haemophilus influenzae, Moraxella Catarrhalis (isolated from a nasopharyngeal swab).
Time Frame
12 months
Title
compare the rate of nasopharyngeal carriage of Streptococcus pneumoniae and PSDP between the sickle cell group and the healthy group of children according to age groups.
Description
Proportion of children with Streptococcus pneumoniae and PSDP (isolated on nasopharyngeal swab) by age group.
Time Frame
12 months
Title
Compare the proportion of non-vaccine serotypes among the Streptococcus pneumoniae strains between the sickle cell group and the healthy group of children.
Description
Proportion of non-vaccine serotypes among nasopharyngeal strains of Streptococcus pneumoniae.
Time Frame
12 months
Title
compare the nasopharyngeal carriage rate of MRSA, Haemophilus influenzae, Moraxella catarrhalis between the sickle cell group and the healthy children group.
Description
Proportion of children with MRSA, Haemophilus influenzae, Moraxella Catarrhalis (isolated on nasopharyngeal swab).
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children aged 6 months to 15 years, regardless of immunization status.
Child with a major sickle cell syndrome (SS, SC, S+, S°, SE) followed in one of the centers of competence or reference for rare diseases (CRMR) " Major sickle cell syndromes, Thalassemias and other rare pathologies of the Red Blood Cell and Erythropoiesis " in Ile de France.
Children who are not subject to legal protection measures.
Child affiliated to a social security system.
Signed informed consent
Exclusion Criteria:
Sickle cell child with a febrile syndrome at the time of sampling or hospitalized for any reason.
Child having received antibiotic therapy other than oracillin in the 7 days preceding the nasopharyngeal swab.
Child already included in the observation period (only 1 nasopharyngeal swab per patient).
Other hemoglobinopathies and heterozygous AS or AC patients.
Patients already involved in a therapeutic protocol or in the exclusion period following a previous research.
Patients under AME or without social security coverage.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luu-Ly PHAM
Phone
0148024405
Email
luu-ly.pham@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
HOUDA ALLALOU
Phone
0148957407
Email
houda.allalou@aphp.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
22329610
Citation
Schaumburg F, Biallas B, Ngoune Feugap E, Alabi AS, Mordmuller B, Kremsner PG, Grobusch MP, Lell B, van der Linden M, Peters G, Adegnika AA. Carriage of encapsulated bacteria in Gabonese children with sickle cell anaemia. Clin Microbiol Infect. 2013 Mar;19(3):235-41. doi: 10.1111/j.1469-0691.2012.03771.x. Epub 2012 Feb 13.
Results Reference
background
PubMed Identifier
30408061
Citation
Dayie NTKD, Tetteh-Ocloo G, Labi AK, Olayemi E, Slotved HC, Lartey M, Donkor ES. Pneumococcal carriage among sickle cell disease patients in Accra, Ghana: Risk factors, serotypes and antibiotic resistance. PLoS One. 2018 Nov 8;13(11):e0206728. doi: 10.1371/journal.pone.0206728. eCollection 2018. Erratum In: PLoS One. 2019 Jan 30;14(1):e0211838.
Results Reference
background
PubMed Identifier
23050673
Citation
Schaumburg F, Biallas B, Alabi AS, Grobusch MP, Feugap EN, Lell B, Mellmann A, Peters G, Kremsner PG, Becker K, Adegnika AA. Clonal structure of Staphylococcus aureus colonizing children with sickle cell anaemia and healthy controls. Epidemiol Infect. 2013 Aug;141(8):1717-20. doi: 10.1017/S0950268812002270. Epub 2012 Oct 10.
Results Reference
background
Learn more about this trial
Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France
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