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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Procedure: nasopharyngeal swabbing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sickle cell children group<br>A nasopharyngeal swab is taken during the consultation, with bacteriological analysis. | Procedure: nasopharyngeal swabbing<br>* A nasopharyngeal swab is collected during the consultation, with bacteriological analysis. No follow-up visit is required for this study<br>|
| No Intervention: control children group<br>healthy children control group (ACTIV network) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 
| 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 | 12 months | 
| 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. | 12 months | 
| 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). | 12 months | 
| 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. | 12 months | 
| 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. | 12 months | 
| 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). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sickle celle disease, Nasopharyngeal bacterial carriage