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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-02-01

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.

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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

Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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sickle cell children group

A nasopharyngeal swab is taken during the consultation, with bacteriological analysis.

Group Type EXPERIMENTAL

nasopharyngeal swabbing

Intervention Type PROCEDURE

A nasopharyngeal swab is collected during the consultation, with bacteriological analysis. No follow-up visit is required for this study

control children group

healthy children control group (ACTIV network)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nasopharyngeal swabbing

A nasopharyngeal swab is collected during the consultation, with bacteriological analysis. No follow-up visit is required for this study

Intervention Type PROCEDURE

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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes