Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT05354258
Status:
UNKNOWN
Last Update Posted:
2022-07-14
First Post:
2022-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility and Safety of Combining Anti-malarial With Deworming Drugs in African Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}, {'id': 'D012552', 'term': 'Schistosomiasis'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D014201', 'term': 'Trematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015766', 'term': 'Albendazole'}, {'id': 'D011223', 'term': 'Praziquantel'}, {'id': 'D000655', 'term': 'Amodiaquine'}, {'id': 'C001205', 'term': 'fanasil, pyrimethamine drug combination'}], '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': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-12', 'studyFirstSubmitDate': '2022-04-12', 'studyFirstSubmitQcDate': '2022-04-26', 'lastUpdatePostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Prevalence of anaemia', 'timeFrame': 'On the day of randomisation (pre-intervention) and up to 4 months post-intervention', 'description': 'Haemoglobin concentration of all study children will be checked using HemoCue®'}], 'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'For six consecutive days after start of the drug administration', 'description': 'Incidence of Treatment-Emergent Adverse Events will be measured by collecting solicited and unsolicited adverse events and adverse drug reactions for causal relationships to the study drugs.'}], 'secondaryOutcomes': [{'measure': 'Prevalence of helminth co-infection', 'timeFrame': 'On the day of randomisation (pre-intervention) and up to 4 months post-intervention', 'description': 'Faecal egg counts for soil transmitted helminths'}, {'measure': 'Prevalence of Schistosoma co-infection', 'timeFrame': 'On the day of randomisation (pre-intervention) and up to 4 months post-intervention', 'description': 'Urine egg counts for Schistosoma haematobium'}, {'measure': 'Prevalence of intensity of helminth infection', 'timeFrame': 'On the day of randomisation (pre-intervention) and up to 4 months post-intervention', 'description': 'Arithmetic mean intensity of helminth infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malaria', 'Soil Transmitted Helminths', 'Schistosomiasis', 'Integrated Control', 'Seasonal Malaria Chemoprevention', 'Mass Drug Administration With Anthelminthic Drugs']}, 'referencesModule': {'references': [{'pmid': '37957702', 'type': 'DERIVED', 'citation': 'Afolabi MO, Sow D, Agbla SC, Fall EHB, Sall FB, Seck A, Manga IA, Mbaye IM, Loum MA, Camara B, Niang D, Gueye B, Sene D, Kane NM, Diop B, Diouf A, Gaye NA, Diouf MP, Lo AC, Greenwood B, Ndiaye JLA. Feasibility and safety of integrating mass drug administration for helminth control with seasonal malaria chemoprevention among Senegalese children: a randomized controlled, observer-blind trial. Malar J. 2023 Nov 13;22(1):348. doi: 10.1186/s12936-023-04784-z.'}, {'pmid': '37722662', 'type': 'DERIVED', 'citation': 'Afolabi MO, Diaw A, Fall EHB, Sall FB, Diedhiou A, Seck A, Camara B, Niang D, Manga IA, Mbaye I, Sougou NM, Sow D, Greenwood B, Ndiaye JLA. Provider and User Acceptability of Integrated Treatment for the Control of Malaria and Helminths in Saraya, South-Eastern Senegal. Am J Trop Med Hyg. 2023 Sep 18;109(5):1047-1056. doi: 10.4269/ajtmh.23-0113. Print 2023 Nov 1.'}, {'pmid': '35922819', 'type': 'DERIVED', 'citation': 'Afolabi MO, Sow D, Ndiaye JLA, Greenwood B. Safety and effectiveness of delivering mass drug administration for helminths through the seasonal malaria chemoprevention platform among Senegalese children: study protocol for a randomised controlled trial. Trials. 2022 Aug 3;23(1):627. doi: 10.1186/s13063-022-06579-0.'}]}, 'descriptionModule': {'briefSummary': 'Malaria remains a major health problem, especially in sub-Saharan Africa where more than 90% of the disease and deaths occur in children. Adding to this high burden among the children is the co-existence of intestinal and genito-urinary worms. Prominent among these are soil-transmitted helminths and schistosomiasis. Existing control programmes for the worms are operating below the expected level, despite the commitments and support that followed the 2012 London Declaration of achieving 75% treatment coverage by 2020. On the other hand, a malaria prevention programme, called Seasonal Malaria Chemoprevention (SMC), introduced in the same year 2012 has achieved more than 75% treatment coverage and prevented 75-85% cases of uncomplicated and severe malaria in children. This encouraging development supports the need to explore the strategies involving the integration of worm control with successful platforms such as SMC. This would align worm and malaria control with the WHO road map for Neglected Tropical Diseases (NTD) of ending the neglect to attain Sustainable Development Goals by eradicating diseases of poverty and promoting health and well-being for those at risk. Given this context, it is important to develop a treatment approach that combines malaria and helminth control in an integrated framework that will be safe, effective and easy to deliver. This study will, therefore, investigate the feasibility and effectiveness of co-administration of anthelminthic and SMC drugs in a high-risk paediatric population living in a malaria-helminth co-endemic setting in Senegal, West Africa. This study is designed to test the hypothesis that co-administration of SMC and anthelminthic drugs will be safe and tolerated among children aged 1-14 years and that the incidence of side effects will not be significant. The objectives of this study are to assess the safety, tolerability, and effects of co-administration of SMC and anthelminthic drugs among the children'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female children aged 1-14 years;\n* Provision of a written informed consent by the parent/caregiver and a positive assent by children aged ≥ 12 years (in line with legal regulations in Senegal);\n* Willingness to provide finger-prick blood samples, urine, and stool samples;\n* Residence in the study area for at least six months\n\nExclusion Criteria:\n\n* Acutely ill child at the time of the drug administration;\n* Child whose parents/caregivers decline to provide consent;\n* A known HIV positive child receiving cotrimoxazole prophylaxis;\n* A child who has received a dose of any of sulphadoxine-pyrimethamine, amodiaquine, albendazole or praziquantel during the previous six months;\n* A child with a known allergy to any of sulphadoxine-pyrimethamine, amodiaquine, albendazole or praziquantel.'}, 'identificationModule': {'nctId': 'NCT05354258', 'acronym': 'MALHELMIN', 'briefTitle': 'Feasibility and Safety of Combining Anti-malarial With Deworming Drugs in African Children', 'organization': {'class': 'OTHER', 'fullName': 'London School of Hygiene and Tropical Medicine'}, 'officialTitle': 'Feasibility and Effectiveness of Delivering Mass Drug Administration for Helminths Through the Seasonal Malaria Chemoprevention (SMC) Platform in a West African Paediatric Population', 'orgStudyIdInfo': {'id': '26770'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Vitamin A + Zinc supplements on Day 0, followed by SMC course on Day 1,2 & 3', 'interventionNames': ['Drug: Amodiaquine', 'Drug: Sulfadoxine pyrimethamine']}, {'type': 'EXPERIMENTAL', 'label': 'Praziquantel + Vitamin A on Day 0, followed SMC course on Days 1,2 & 3', 'interventionNames': ['Drug: Praziquantel', 'Drug: Amodiaquine', 'Drug: Sulfadoxine pyrimethamine']}, {'type': 'EXPERIMENTAL', 'label': 'Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3', 'interventionNames': ['Drug: Albendazole', 'Drug: Praziquantel', 'Drug: Amodiaquine', 'Drug: Sulfadoxine pyrimethamine']}], 'interventions': [{'name': 'Albendazole', 'type': 'DRUG', 'description': 'Anthelminthic drugs for the treatment of soil-transmitted helminths', 'armGroupLabels': ['Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3']}, {'name': 'Praziquantel', 'type': 'DRUG', 'description': 'Anthelminthic drugs for the treatment of schistosomiasis', 'armGroupLabels': ['Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3', 'Praziquantel + Vitamin A on Day 0, followed SMC course on Days 1,2 & 3']}, {'name': 'Amodiaquine', 'type': 'DRUG', 'description': 'SMC partner drug', 'armGroupLabels': ['Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3', 'Praziquantel + Vitamin A on Day 0, followed SMC course on Days 1,2 & 3', 'Vitamin A + Zinc supplements on Day 0, followed by SMC course on Day 1,2 & 3']}, {'name': 'Sulfadoxine pyrimethamine', 'type': 'DRUG', 'description': 'SMC partner drug', 'armGroupLabels': ['Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3', 'Praziquantel + Vitamin A on Day 0, followed SMC course on Days 1,2 & 3', 'Vitamin A + Zinc supplements on Day 0, followed by SMC course on Day 1,2 & 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00221', 'city': 'Saraya', 'state': 'Région de Kédougou', 'country': 'Senegal', 'facility': 'Saraya Health Centre', 'geoPoint': {'lat': 12.83167, 'lon': -11.75381}}], 'overallOfficials': [{'name': 'Brian Greenwood, MD, FMedSci', 'role': 'STUDY_DIRECTOR', 'affiliation': 'London School of Hygiene and Tropical Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Within 12 months of the study completion date', 'ipdSharing': 'YES', 'description': 'We will share the summary results of this trial or a link to the summary results within the trial registration record within 12 months of the study completion date', 'accessCriteria': 'Open access requests will be entertained, the decision will be made by the Principal Investigator, quality of the request will be reviewed before granting it'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université de Thies, UFR Santé, Senegal', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}