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

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ClinicalTrials.gov Identifier: NCT05197205
Recruitment Status : Not yet recruiting
First Posted : January 19, 2022
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Procedure: nasopharyngeal swabbing Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France
Estimated Study Start Date : February 1, 2022
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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).


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05197205


Contacts
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Contact: Luu-Ly PHAM 0148024405 luu-ly.pham@aphp.fr
Contact: HOUDA ALLALOU 0148957407 houda.allalou@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
More Information
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Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT05197205    
Other Study ID Numbers: APHP211360
First Posted: January 19, 2022    Key Record Dates
Last Update Posted: January 19, 2022
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Sickle celle disease, Nasopharyngeal bacterial carriage
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn