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

January 4, 2022 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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.
Time Frame: 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.
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.
Time Frame: 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.
12 months
determine the proportion of vaccine serotypes among pneumococcal strains in children with sickle cell disease aged over 6 months and under 15
Time Frame: 12 months
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.
Time Frame: 12 months
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.
Time Frame: 12 months
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.
Time Frame: 12 months
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.
Time Frame: 12 months
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.
Time Frame: 12 months
Proportion of children with MRSA, Haemophilus influenzae, Moraxella Catarrhalis (isolated on nasopharyngeal swab).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2022

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

December 9, 2021

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP211360

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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