Viewing Study NCT05197205


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Study NCT ID: NCT05197205
Status: UNKNOWN
Last Update Posted: 2022-01-19
First Post: 2021-12-09
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France
Sponsor: Assistance Publique - Hôpitaux de Paris
Organization:

Study Overview

Official Title: Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France
Status: UNKNOWN
Status Verified Date: 2021-10
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: DREPANO-BACT
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: