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

Sickle Cell Disease Clinical Trial

— DREPANO-BACT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05197205
• Other study ID #: APHP211360
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: October 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Luu-Ly PHAM
• Phone: 0148024405
• Email: luu-ly.pham[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

References & Publications (3)

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. — View 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. — View Citation

Schaumburg F, Biallas B, Ngoune Feugap E, Alabi AS, Mordmüller 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 months
Secondary	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	12 months
Secondary	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.	12 months
Secondary	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).	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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).	12 months