Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT00709969
Status:
COMPLETED
Last Update Posted:
2008-07-03
First Post:
2008-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016778', 'term': 'Malaria, Falciparum'}, {'id': 'D008288', 'term': 'Malaria'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2003-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-02', 'studyFirstSubmitDate': '2008-07-02', 'studyFirstSubmitQcDate': '2008-07-02', 'lastUpdatePostDateStruct': {'date': '2008-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events, SAEs; hematology and biochemistry parameters; electrocardiogram; urine values; vital signs; physical neurological examinations; and neurological examinations', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients free of parasites at 7, 14 and at 28 days'}, {'measure': 'Time to clearance from parasites (asexual forms)'}, {'measure': 'Time to clearance of fever'}, {'measure': 'Time to clearance of gametocytes (parasite sexual forms)'}]}, 'conditionsModule': {'keywords': ['Malaria', 'co-artemether', 'auditory', 'Plasmodium falciparum', 'marsh fever', 'remittent fever', 'artemether', 'artemisinins', 'lumefantrine', 'child', 'infant', 'Africa'], 'conditions': ['Plasmodium Falciparum Malaria']}, 'referencesModule': {'references': [{'pmid': '19038036', 'type': 'DERIVED', 'citation': 'Falade CO, Ogunkunle OO, Dada-Adegbola HO, Falade AG, de Palacios PI, Hunt P, Virtanen M, Oduola AM, Salako LA. Evaluation of the efficacy and safety of artemether-lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in Nigerian infants and children. Malar J. 2008 Nov 27;7:246. doi: 10.1186/1475-2875-7-246.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety and efficacy of artemether-lumefantrine tablets (6-dose regimen) in African infants / children with acute uncomplicated falciparum malaria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female weighing ≥ 5kg and ≤ 25kg\n* P. falciparum parasitemia between 1,000 and 100,000 parasites/mm3\n* with confirmed diagnosis of uncomplicated malaria caused P. falciparum parasite\n\nExclusion Criteria:\n\n* complicated malaria\n* ingestion of various antimalarial drugs, or other drugs influencing cardiac function in the previous 4 weeks before study entry to 8 weeks\n* severe anaemia\n* severe malnutrition\n* malaria due to other than P. falciparum\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00709969', 'briefTitle': 'Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Open Label, Multicenter Study for Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets (6-Dose Regimen) in African Infants and Children in the Treatment of Acute Uncomplicated Falciparum Malaria', 'orgStudyIdInfo': {'id': 'CCOA566A2403'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Artemether-lumefantrine', 'interventionNames': ['Drug: Artemether-lumefantrine']}], 'interventions': [{'name': 'Artemether-lumefantrine', 'type': 'DRUG', 'otherNames': ['Coartem®, Riamet®, co-artemether'], 'description': '20mg artemether and 120 mg lumefantrine, tablet, dose based on body weight, 3 days treatment 5 - \\< 10kg (BWG 1) = 6 doses of 1 tablet / 10 - \\< 15kg (BWG 2) = 6 doses of 1 tablet / 15 - ≤ 25kg (BWG 3) = 6 doses of 2 tablets', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kilifi', 'country': 'Kenya', 'facility': 'Kemri-Wellcome Trust Programme', 'geoPoint': {'lat': -3.63045, 'lon': 39.84992}}, {'city': 'Ibadan', 'country': 'Nigeria', 'facility': 'University College Hospital Malaria Research Laboratories Institute for Advance Medical Research and Training', 'geoPoint': {'lat': 7.37756, 'lon': 3.90591}}, {'city': 'Dar es Salaam', 'country': 'Tanzania', 'facility': 'Muhimbili University College of Health Sciences Department of Parasitology and Medical Entomology, Box 65011', 'geoPoint': {'lat': -6.82349, 'lon': 39.26951}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'World Health Organization', 'class': 'OTHER'}, {'name': 'Avenue Appia 20', 'class': 'UNKNOWN'}, {'name': 'CH - 1211 Geneva 27', 'class': 'UNKNOWN'}, {'name': 'Switzerland', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis'}}}}