Clinical trial NCT05197205: Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France
Official title: Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Sickle celle disease, Nasopharyngeal bacterial carriage
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 600
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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

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.

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 12 months
measure: determine the proportion of vaccine serotypes among pneumococcal strains in children with sickle cell disease aged over 6 months and under 15
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
measure: Compare the proportion of non-vaccine serotypes among the Streptococcus pneumoniae strains between the sickle cell group and the healthy group of children.
timeFrame: 12 months
measure: compare the nasopharyngeal carriage rate of MRSA, Haemophilus influenzae, Moraxella catarrhalis between the sickle cell group and the healthy children group.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.