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

A

Assistance Publique - Hôpitaux de Paris

Status

Unknown

Conditions

Sickle Cell Disease

Treatments

Procedure: nasopharyngeal swabbing

Study type

Interventional

Funder types

Other

Identifiers

NCT05197205
APHP211360

Details and patient eligibility

About

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.

Full 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

Enrollment

600 estimated patients

Sex

All

Ages

6 months to 15 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

600 participants in 2 patient groups

sickle cell children group
Experimental group
Description:
A nasopharyngeal swab is taken during the consultation, with bacteriological analysis.
Treatment:
Procedure: nasopharyngeal swabbing
control children group
No Intervention group
Description:
healthy children control group (ACTIV network)

Trial contacts and locations

0

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Central trial contact

HOUDA ALLALOU; Luu-Ly PHAM

Data sourced from clinicaltrials.gov

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