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

Primary Purpose

Sickle Cell Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nasopharyngeal swabbing
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sickle Cell Disease focused on measuring Sickle celle disease, Nasopharyngeal bacterial carriage

Eligibility Criteria

6 Months - 15 Years (Child)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    sickle cell children group

    control children group

    Arm Description

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

    healthy children control group (ACTIV network)

    Outcomes

    Primary Outcome Measures

    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.
    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

    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.
    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.
    determine the proportion of vaccine serotypes among pneumococcal strains in children with sickle cell disease aged over 6 months and under 15
    Proportion of children with vaccine serotypes among the pneumococcal strains
    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.
    Proportion of non-vaccine serotypes among all pneumococcal strains.
    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.
    Proportion of children with MRSA, Haemophilus influenzae, Moraxella Catarrhalis (isolated from a nasopharyngeal swab).
    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.
    Proportion of children with Streptococcus pneumoniae and PSDP (isolated on nasopharyngeal swab) by age group.
    Compare the proportion of non-vaccine serotypes among the Streptococcus pneumoniae strains between the sickle cell group and the healthy group of children.
    Proportion of non-vaccine serotypes among nasopharyngeal strains of Streptococcus pneumoniae.
    compare the nasopharyngeal carriage rate of MRSA, Haemophilus influenzae, Moraxella catarrhalis between the sickle cell group and the healthy children group.
    Proportion of children with MRSA, Haemophilus influenzae, Moraxella Catarrhalis (isolated on nasopharyngeal swab).

    Full Information

    First Posted
    December 9, 2021
    Last Updated
    January 4, 2022
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05197205
    Brief Title
    Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France
    Acronym
    DREPANO-BACT
    Official Title
    Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2022 (Anticipated)
    Primary Completion Date
    February 1, 2022 (Anticipated)
    Study Completion Date
    February 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sickle Cell Disease
    Keywords
    Sickle celle disease, Nasopharyngeal bacterial carriage

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    sickle cell children group
    Arm Type
    Experimental
    Arm Description
    A nasopharyngeal swab is taken during the consultation, with bacteriological analysis.
    Arm Title
    control children group
    Arm Type
    No Intervention
    Arm Description
    healthy children control group (ACTIV network)
    Intervention Type
    Procedure
    Intervention Name(s)
    nasopharyngeal swabbing
    Intervention Description
    A nasopharyngeal swab is collected during the consultation, with bacteriological analysis. No follow-up visit is required for this study
    Primary Outcome Measure Information:
    Title
    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.
    Description
    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.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    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.
    Description
    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.
    Time Frame
    12 months
    Title
    determine the proportion of vaccine serotypes among pneumococcal strains in children with sickle cell disease aged over 6 months and under 15
    Description
    Proportion of children with vaccine serotypes among the pneumococcal strains
    Time Frame
    12 months
    Title
    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.
    Description
    Proportion of non-vaccine serotypes among all pneumococcal strains.
    Time Frame
    12 months
    Title
    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.
    Description
    Proportion of children with MRSA, Haemophilus influenzae, Moraxella Catarrhalis (isolated from a nasopharyngeal swab).
    Time Frame
    12 months
    Title
    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.
    Description
    Proportion of children with Streptococcus pneumoniae and PSDP (isolated on nasopharyngeal swab) by age group.
    Time Frame
    12 months
    Title
    Compare the proportion of non-vaccine serotypes among the Streptococcus pneumoniae strains between the sickle cell group and the healthy group of children.
    Description
    Proportion of non-vaccine serotypes among nasopharyngeal strains of Streptococcus pneumoniae.
    Time Frame
    12 months
    Title
    compare the nasopharyngeal carriage rate of MRSA, Haemophilus influenzae, Moraxella catarrhalis between the sickle cell group and the healthy children group.
    Description
    Proportion of children with MRSA, Haemophilus influenzae, Moraxella Catarrhalis (isolated on nasopharyngeal swab).
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luu-Ly PHAM
    Phone
    0148024405
    Email
    luu-ly.pham@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    HOUDA ALLALOU
    Phone
    0148957407
    Email
    houda.allalou@aphp.fr

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22329610
    Citation
    Schaumburg F, Biallas B, Ngoune Feugap E, Alabi AS, Mordmuller B, Kremsner PG, Grobusch MP, Lell B, van der Linden M, Peters G, Adegnika AA. Carriage of encapsulated bacteria in Gabonese children with sickle cell anaemia. Clin Microbiol Infect. 2013 Mar;19(3):235-41. doi: 10.1111/j.1469-0691.2012.03771.x. Epub 2012 Feb 13.
    Results Reference
    background
    PubMed Identifier
    30408061
    Citation
    Dayie NTKD, Tetteh-Ocloo G, Labi AK, Olayemi E, Slotved HC, Lartey M, Donkor ES. Pneumococcal carriage among sickle cell disease patients in Accra, Ghana: Risk factors, serotypes and antibiotic resistance. PLoS One. 2018 Nov 8;13(11):e0206728. doi: 10.1371/journal.pone.0206728. eCollection 2018. Erratum In: PLoS One. 2019 Jan 30;14(1):e0211838.
    Results Reference
    background
    PubMed Identifier
    23050673
    Citation
    Schaumburg F, Biallas B, Alabi AS, Grobusch MP, Feugap EN, Lell B, Mellmann A, Peters G, Kremsner PG, Becker K, Adegnika AA. Clonal structure of Staphylococcus aureus colonizing children with sickle cell anaemia and healthy controls. Epidemiol Infect. 2013 Aug;141(8):1717-20. doi: 10.1017/S0950268812002270. Epub 2012 Oct 10.
    Results Reference
    background

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

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