Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
Study NCT ID:
NCT04326868
Status:
COMPLETED
Last Update Posted:
2021-08-02
First Post:
2020-03-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Human Soil Transmitted Helminths (STH) Resistance to Benzimidazole in School Aged Children Living in Gabon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015766', 'term': 'Albendazole'}, {'id': 'D008463', 'term': 'Mebendazole'}, {'id': 'D011715', 'term': 'Pyrantel'}], 'ancestors': [{'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The participants diagnosed positive for Soil Helminths Infection will be randomly assigned to one of the following treatment arms of the study.\n\nParents or guardians of eligible children will be asked to bring them to the CERMEL (clinic). after a brief clinical examination child fulfilling inclusion criteria will be randomly assigned to one of the following treatment regimens of the study. These regimens consisted of treatment as follow: given as a single tablet once daily for 3 consecutive days\n\n* A single tablet of ABZ (400mg), administered during 3 consecutive days;\n* 1 tablet of ABZ 400mg + 1 tablet of MBZ (500mg) administered in 3 consecutive days,\n* 1 tablet of ABZ (400mg) + Pyr (125 mg) administered in 3 consecutive days'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 255}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-26', 'studyFirstSubmitDate': '2020-03-04', 'studyFirstSubmitQcDate': '2020-03-26', 'lastUpdatePostDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of eggs rate reduction .', 'timeFrame': 'three weeks to six weeks', 'description': 'The assessment of efficacy will be the level of the eggs rate reduction . The assessment will be done at weeks 3 and 6 and a different treatment regimen will be compared according to protocol and intention to treat.\n\nThis evaluation will be based on the same parasitological examinations carried out at the beginning. Using polymerase chain reaction(PCR) for a better, appreciation of the efficacy of Benzimidazole.'}, {'measure': 'Assessment of cure rate', 'timeFrame': 'three weeks to six weeks', 'description': 'The assessment of efficacy as a cure rate, based on the absence of eggs at three and six weeks post treatment, using microscopy and PRC examination.'}], 'secondaryOutcomes': [{'measure': 'The assessment of safety', 'timeFrame': 'three to six weeks.', 'description': 'The adverse events due to a drug intake and the frequency of single nucleotide polymorphisms (SNPs) before and after treatment in each group.The safety of administration of Benzimidazole will be evaluated primarily clinically. The safety will be evaluated within 24 hours and at any unscheduled visit or at week 3 and week 6 to record any symptoms that occur after the drug has been administered.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helminths', 'Resistance', 'Gabon', 'Infection', 'CERMEL', 'Benzimidazole'], 'conditions': ['Helminths Infection', 'Drug Resistance']}, 'referencesModule': {'references': [{'pmid': '38563751', 'type': 'DERIVED', 'citation': "Nguema Moure PA, Nzamba Maloum M, Manouana GP, Laclong Lontchi R-A, Mbong Ngwese M, Edoa JR, Frejus Zinsou J, Meulah B, Mahmoudou S, N'noh Dansou EM, Josiane Honkpehedji Y, Romeo Adegbite B, Agnandji ST, Ramharter M, Lell B, Borrmann S, Kremsner PG, Dejon-Agobe JC, Adegnika AA. A randomized assessors-blind clinical trial to evaluate the safety and the efficacy of albendazole alone and in combination with mebendazole or pyrantel for the treatment of Trichuris trichiura infection in school-aged children in Lambarene and surroundings. Antimicrob Agents Chemother. 2024 May 2;68(5):e0121123. doi: 10.1128/aac.01211-23. Epub 2024 Apr 2."}]}, 'descriptionModule': {'briefSummary': 'Soil-transmitted helminths (STHs) infections are common in subtropics and mostly affect the poorest communities, with an impact on human health in many parts of the world. In 2017, World Health organization (WHO) reports more than 1.5 billion people are infected with soil-transmitted helminths worldwide, including 568 million school-age children who need treatment and preventive interventions. Preventive chemotherapy and periodic mass administration with benzimidazoles (BZ) \\[albendazole (ABZ) and mebendazole (MBZ)\\] are used to control these parasites. However, rapid reinfection with Ascaris lumbricoides within six months after a completed treatment has been reported, while the reinfection with hookworms is slow. Similarly, the efficacy of these drugs on Trichuris trichiura cure rate is poor. After many years of use of this drug class, there is an increase possibility that BZ resistance could develop. This resistance may occur due to single nucleotide polymorphisms (SNPs) in the β-tubulin gene at positions 167, 198 or 200, as has been reported in animals. Little data exist to show whether any of these polymorphisms do influence the BZ efficacy against STH in humans. The present study will develop methods to look for molecular evidence of BZ drug resistance in human population in order to support the investigation of the control and elimination of neglected tropical diseases (NTDs) in our communities.', 'detailedDescription': 'A Randomized Controlled Clinical Trial (RCT) cohort study, to evaluate the efficacy and safety of three benzimidazole derivates drug (Albendazole, Mebendazole, Albendazole Mebendazole, and Albendazole-Pyrantel) to treat major STH in school aged children from Lambaréné and surroundings. After obtaining informed consent from parents or guardians, stool samples will be collected, for infectious status. If positive the participant will be treated with either drug combination. The efficacy and SNP frequencies will be assessed at weeks 3 and 6 post treatment\n\nDescription of study population Children of school and preschool age (2 to 17 years old) living in Lambaréné and the surrounding areas are eligible. The choice of school and preschool-aged children is based on the fact that they constitute the main population at risk of infection. In addition, most of the resources available for public health interventions in many endemic areas of soil-transmitted helminths target this group as a cost-effective method for reaching a large part of the population.\n\nThe previous analysis of patient cohort reported a success rate of 61% multispecies prevalence amongst children in the study area and considering a significance level of 95% confidence interval (α =5%) and a minimum power of 80%, the investigators will have to include a total of 255 participants in the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Living in Lambaréné and surrounding areas\n* Written informed consent or assent\n* Microscopy positive for any major Soil-Transmitted helminths\n\nExclusion Criteria:\n\n* Microscopy negative for any STH\n* Pregnant women\n* Do not be available for followed up.'}, 'identificationModule': {'nctId': 'NCT04326868', 'acronym': 'BenziR', 'briefTitle': 'Human Soil Transmitted Helminths (STH) Resistance to Benzimidazole in School Aged Children Living in Gabon', 'organization': {'class': 'OTHER', 'fullName': 'Centre de Recherche Médicale de Lambaréné'}, 'officialTitle': 'Human Soil Transmitted Helminths (STH) Resistance to Benzimidazole in School Aged Children Living in Gabon', 'orgStudyIdInfo': {'id': '0084/2019/PR/SG/CNER'}, 'secondaryIdInfos': [{'id': 'CEI- 007/2019', 'type': 'OTHER', 'domain': 'Institutional ethics committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Albendazole', 'description': 'ABZ (400mg)', 'interventionNames': ['Drug: Benzimidazole Anthelmintic']}, {'type': 'EXPERIMENTAL', 'label': 'Albendazole and Mebendazole', 'description': 'ABZ 400mg + 1 tablet of MBZ (500mg)', 'interventionNames': ['Drug: Benzimidazole Anthelmintic']}, {'type': 'EXPERIMENTAL', 'label': 'Albendazole and Pyrantel', 'description': 'ABZ (400mg) + Pyr (125 mg)', 'interventionNames': ['Drug: Benzimidazole Anthelmintic']}], 'interventions': [{'name': 'Benzimidazole Anthelmintic', 'type': 'DRUG', 'otherNames': ['Albendazole', 'Mebendazole', 'Pyrantel'], 'description': 'The participants diagnosed positive will be randomly assigned to one of the following treatment arms of the study. Parents or guardians of eligible children will be asked to bring them to the CERMEL (clinic). after a brief clinical examination child fulfilling inclusion criteria will be randomly assigned to one of the following treatment regimens of the study.', 'armGroupLabels': ['Albendazole', 'Albendazole and Mebendazole', 'Albendazole and Pyrantel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1437', 'city': 'Lambaréné', 'state': 'Moyen-Ogooué Province', 'country': 'Gabon', 'facility': 'Centre de Recherches Médicales de Lammbaréné', 'geoPoint': {'lat': -0.7001, 'lon': 10.24055}}], 'overallOfficials': [{'name': 'Ayôla Akim ADEGNIKA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de Recherche Médicale de Lambaréné'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The date will be available around December 2020 until september 2021.', 'ipdSharing': 'YES', 'description': 'The Data will be shared in RedCap database.', 'accessCriteria': 'The Data will be shared12 months after study completion in research journal. A lle the result will be publicly available the'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre de Recherche Médicale de Lambaréné', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}