NCT05197205

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

January 19, 2022

Status Verified

October 1, 2021

Enrollment Period

Same day

First QC Date

December 9, 2021

Last Update Submit

January 4, 2022

Conditions

Sickle Cell Disease

Keywords

Sickle celle disease, Nasopharyngeal bacterial carriage

Outcome Measures

Primary Outcomes (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.

    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 Outcomes (7)

  • 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.

    12 months

  • determine the proportion of vaccine serotypes among pneumococcal strains in children with sickle cell disease aged over 6 months and under 15

    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.

    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.

    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.

    12 months

  • +2 more secondary outcomes

Study Arms (2)

sickle cell children group

EXPERIMENTAL

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

Procedure: nasopharyngeal swabbing

control children group

NO INTERVENTION

healthy children control group (ACTIV network)

Interventions

nasopharyngeal swabbingPROCEDURE

A nasopharyngeal swab is collected during the consultation, with bacteriological analysis. No follow-up visit is required for this study

sickle cell children group

Eligibility Criteria

Age6 Months - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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 under AME or without social security coverage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 22329610BACKGROUND

  • 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.

    PMID: 30408061BACKGROUND

  • 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.

    PMID: 23050673BACKGROUND

  • Pham LL, Varon E, Bonacorsi S, Boubaya M, Benhaim P, Amor-Chelihi L, Houlier M, Koehl B, Missud F, Brousse V, Gajdos V, Bizot E, Briand C, Malka A, Odievre MH, Romain AS, Hau I, Pondarre C, See H, Guitton C, Zenkhri F, Holvoet L, Benkerrou M, Da Silveira C, Belaid N, Laurent O, Vassal M, Basmaci R, Aupiais C, Bloch-Queyrat C, Levy C, Cohen R, Ouldali N, De Pontual L, Carbonnelle E, Gaschignard J. Nasopharyngeal Carriage and Antibiotic Resistance in Children With Sickle Cell Disease: The DREPANOBACT French Multicenter Prospective Study. Pediatr Infect Dis J. 2025 May 1;44(5):387-393. doi: 10.1097/INF.0000000000004744. Epub 2025 Feb 3.

    PMID: 40232881DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Luu-Ly PHAM

CONTACT

0148024405luu-ly.pham@aphp.fr

HOUDA ALLALOU

CONTACT

0148957407houda.allalou@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2021

First Posted

January 19, 2022

Study Start

February 1, 2022

Primary Completion

February 1, 2022

Study Completion

February 1, 2023

Last Updated

January 19, 2022

Record last verified: 2021-10