Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT00460369
Status:
COMPLETED
Last Update Posted:
2008-04-14
First Post:
2007-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Uncomplicated Malaria in Benin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C001205', 'term': 'fanasil, pyrimethamine drug combination'}, {'id': 'D000077611', 'term': 'Artemether, Lumefantrine Drug Combination'}], 'ancestors': [{'id': 'D000077549', 'term': 'Artemether'}, {'id': 'D037621', 'term': 'Artemisinins'}, {'id': 'D017382', 'term': 'Reactive Oxygen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000078102', 'term': 'Lumefantrine'}, {'id': 'D005449', 'term': 'Fluorenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D012717', 'term': 'Sesquiterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-11', 'studyFirstSubmitDate': '2007-04-12', 'studyFirstSubmitQcDate': '2007-04-12', 'lastUpdatePostDateStruct': {'date': '2008-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy', 'timeFrame': 'day 28'}], 'secondaryOutcomes': [{'measure': 'effectiveness comparisons (PCR corrected)', 'timeFrame': 'day 14 and day 42'}, {'measure': 'incidence of adverse events', 'timeFrame': 'day 42'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['uncomplicated malaria', 'children', 'treatment', 'effectiveness'], 'conditions': ['Uncomplicated Malaria']}, 'referencesModule': {'references': [{'pmid': '19469703', 'type': 'DERIVED', 'citation': 'Faucher JF, Aubouy A, Adeothy A, Cottrell G, Doritchamou J, Gourmel B, Houze P, Kossou H, Amedome H, Massougbodji A, Cot M, Deloron P. Comparison of sulfadoxine-pyrimethamine, unsupervised artemether-lumefantrine, and unsupervised artesunate-amodiaquine fixed-dose formulation for uncomplicated plasmodium falciparum malaria in Benin: a randomized effectiveness noninferiority trial. J Infect Dis. 2009 Jul 1;200(1):57-65. doi: 10.1086/599378.'}]}, 'descriptionModule': {'briefSummary': 'Malaria is a life-threatening disease especially in small children. A high degree of Plasmodium falciparum resistance to chloroquine has already spread to South-Benin where this study is taking place. In the past few years, the recommendation for a first-line treatment in this area has moved from chloroquine to sulfadoxine-pyrimethamine (SP). There is growing evidence that Plasmodium falciparum resistance to SP has come to South-Benin. The aim of the study is to compare the efficacy of SP to two compact artemisinin-based therapies (ACT): artemether-lumefantrine and the amodiaquine-artesunate coformulation. ACT will be unsupervised.\n\nThe primary endpoint is an effectiveness comparison (PCR corrected) at day 28. Secondary outcomes are effectiveness comparisons (PCR corrected) at day 14 and 42 and a study on the relationships between ACT PK data (day 3) and outcome.\n\nExpected total enrollment: 225 patients\n\nStudy start: April 2007; expected completion: December 2007'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '119 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6-119 months old\n* fever or history of fever of less than 24 hours\n* p falciparum parasitemia \\> 1000 trophozoïtes/µL\n* informed consent signed\n\nExclusion Criteria:\n\n* \\< 5 kg\n* danger or severity signs of malaria\n* known underlying chronic disease\n* Hb \\< 5g/dL\n* adequate malaria treatment taken within 3 days before visit'}, 'identificationModule': {'nctId': 'NCT00460369', 'briefTitle': 'Treatment of Uncomplicated Malaria in Benin', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut de Recherche pour le Developpement'}, 'officialTitle': 'Sulfadoxine-Pyrimethamine Versus Artemether-Lumefantrine Versus Amodiaquine-Artesunate Coformulation in Uncomplicated Plasmodium Falciparum Malaria : an Open Randomized Study', 'orgStudyIdInfo': {'id': 'Malariallada'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'sulfadoxine-pyrimethamine', 'interventionNames': ['Drug: sulfadoxine-pyrimethamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'artemether-lumefantrine', 'interventionNames': ['Drug: artemether-lumefantrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'amodiaquine-artesunate coformulation', 'interventionNames': ['Drug: amodiaquine-artesunate coformulation']}], 'interventions': [{'name': 'sulfadoxine-pyrimethamine', 'type': 'DRUG', 'otherNames': ['Fansidar'], 'description': 'tablets 1,25/25 mg\n\n1 tablet per 20 kg of body weight Single drug intake', 'armGroupLabels': ['1']}, {'name': 'artemether-lumefantrine', 'type': 'DRUG', 'otherNames': ['coartem'], 'description': 'tablets 20/120 mg\n\n* 1 tablet twice daily for 3 days below 15 kg of bodyweight\n* 2 tablets twice daily for 3 days below 24 kg of bodyweight\n* 3 tablets twice daily for 3 days below 35 kg of bodyweight', 'armGroupLabels': ['2']}, {'name': 'amodiaquine-artesunate coformulation', 'type': 'DRUG', 'otherNames': ['coarsucam'], 'description': 'one 25mg/67,5mg tablet, once daily for 3 days below 9 kg\n\none 50/135mg tablet, once daily for 3 days below 18 kg', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Allada', 'country': 'Benin', 'facility': 'Centre de santé', 'geoPoint': {'lat': 6.66547, 'lon': 2.15138}}], 'overallOfficials': [{'name': 'Jean-François Faucher, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de recherche pour le développement UR010'}, {'name': 'Philippe Deloron, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut de Recherche pour le Développement UR010'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Recherche pour le Developpement', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Faucher', 'oldOrganization': 'Institut de Recherche pour le Développement'}}}}