Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT05197205
Status:
UNKNOWN
Last Update Posted:
2022-01-19
First Post:
2021-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-04', 'studyFirstSubmitDate': '2021-12-09', 'studyFirstSubmitQcDate': '2022-01-04', 'lastUpdatePostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', '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.'}], 'secondaryOutcomes': [{'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', '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.'}, {'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', 'description': 'Proportion of children with vaccine serotypes among the pneumococcal strains'}, {'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', 'description': 'Proportion of non-vaccine serotypes among all pneumococcal strains.'}, {'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', 'description': 'Proportion of children with MRSA, Haemophilus influenzae, Moraxella Catarrhalis (isolated from a nasopharyngeal swab).'}, {'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', 'description': 'Proportion of children with Streptococcus pneumoniae and PSDP (isolated on nasopharyngeal swab) by age group.'}, {'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', 'description': 'Proportion of non-vaccine serotypes among nasopharyngeal strains of Streptococcus pneumoniae.'}, {'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', 'description': 'Proportion of children with MRSA, Haemophilus influenzae, Moraxella Catarrhalis (isolated on nasopharyngeal swab).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sickle celle disease, Nasopharyngeal bacterial carriage'], 'conditions': ['Sickle Cell Disease']}, 'referencesModule': {'references': [{'pmid': '22329610', 'type': 'BACKGROUND', '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.'}, {'pmid': '30408061', 'type': 'BACKGROUND', '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.'}, {'pmid': '23050673', 'type': 'BACKGROUND', '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.'}, {'pmid': '40232881', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nChildren 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.\n\nthe 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.\n\nHowever, data concerning the carriage of resistant bacteria (prevalence, risk factors) in children with sickle cell disease in France are scarce.\n\nThis study aims to determine the nasopharyngeal bacterial carriage and antibiotic resistance in children with sickle cell disease in Ile-De-France'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 6 months to 15 years, regardless of immunization status.\n* 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.\n* Children who are not subject to legal protection measures.\n* Child affiliated to a social security system.\n* Signed informed consent\n\nExclusion Criteria:\n\n* Sickle cell child with a febrile syndrome at the time of sampling or hospitalized for any reason.\n* Child having received antibiotic therapy other than oracillin in the 7 days preceding the nasopharyngeal swab.\n* Child already included in the observation period (only 1 nasopharyngeal swab per patient).\n* Other hemoglobinopathies and heterozygous AS or AC patients.\n* Patients already involved in a therapeutic protocol or in the exclusion period following a previous research.\n* Patients under AME or without social security coverage.'}, 'identificationModule': {'nctId': 'NCT05197205', 'acronym': 'DREPANO-BACT', 'briefTitle': 'Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France', 'orgStudyIdInfo': {'id': 'APHP211360'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sickle cell children group', 'description': 'A nasopharyngeal swab is taken during the consultation, with bacteriological analysis.', 'interventionNames': ['Procedure: nasopharyngeal swabbing']}, {'type': 'NO_INTERVENTION', 'label': 'control children group', 'description': 'healthy children control group (ACTIV network)'}], 'interventions': [{'name': 'nasopharyngeal swabbing', 'type': 'PROCEDURE', 'description': 'A nasopharyngeal swab is collected during the consultation, with bacteriological analysis. No follow-up visit is required for this study', 'armGroupLabels': ['sickle cell children group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Luu-Ly PHAM', 'role': 'CONTACT', 'email': 'luu-ly.pham@aphp.fr', 'phone': '0148024405'}, {'name': 'HOUDA ALLALOU', 'role': 'CONTACT', 'email': 'houda.allalou@aphp.fr', 'phone': '0148957407'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}