Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France

Not Applicable

• Conditions: Sickle Cell Disease
• Interventions: Procedure: nasopharyngeal swabbing

• Registration Number: NCT05197205
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2022-01-04
• Last Update Submitted: 2022-01-04
• Study First Posted: 2022-01-19
• Last Update Posted: 2022-01-19
• Study Start: 2022-02-01
• Primary Completion: 2022-02-01
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sickle cell children group	nasopharyngeal swabbing	A nasopharyngeal swab is taken during the consultation, with bacteriological analysis.

Primary Outcome Measures

Name	Time	Method
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.	12 months	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

Name	Time	Method
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.	12 months	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 non-vaccine serotypes among all pneumococcal strains in children with sickle cell disease over 6 months and under 15 years of age.	12 months	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.	12 months	Proportion of children with MRSA, Haemophilus influenzae, Moraxella Catarrhalis (isolated from a nasopharyngeal swab).
compare the nasopharyngeal carriage rate of MRSA, Haemophilus influenzae, Moraxella catarrhalis between the sickle cell group and the healthy children group.	12 months	Proportion of children with MRSA, Haemophilus influenzae, Moraxella Catarrhalis (isolated on 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.	12 months	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.	12 months	Proportion of non-vaccine serotypes among nasopharyngeal strains of Streptococcus pneumoniae.
determine the proportion of vaccine serotypes among pneumococcal strains in children with sickle cell disease aged over 6 months and under 15	12 months	Proportion of children with vaccine serotypes among the pneumococcal strains