Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-26 @ 10:22 PM
Study NCT ID:
NCT00529867
Status:
COMPLETED
Last Update Posted:
2008-01-18
First Post:
2007-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomised Efficacy Study of Two Artemether-Lumefantrine Oral Formulations for the Treatment of Uncomplicated P. Falciparum Malaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016778', 'term': 'Malaria, Falciparum'}], 'ancestors': [{'id': 'D008288', 'term': 'Malaria'}, {'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': 'D000077549', 'term': 'Artemether'}, {'id': 'D000078102', 'term': 'Lumefantrine'}, {'id': 'D000077611', 'term': 'Artemether, Lumefantrine Drug Combination'}], 'ancestors': [{'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': 'D012717', 'term': 'Sesquiterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D005449', 'term': 'Fluorenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 267}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-17', 'studyFirstSubmitDate': '2007-09-12', 'studyFirstSubmitQcDate': '2007-09-12', 'lastUpdatePostDateStruct': {'date': '2008-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare PCR corrected cure-rates on day 14 and 28', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'To determine and compare Adequate Clinical and Parasitological Response (ACPR) at days 14 and 28', 'timeFrame': '28 days'}, {'measure': 'To determine and compare proportion of children with gametocytes on days 0, 7, 14, and 28', 'timeFrame': '28 days'}, {'measure': 'Monitor any possible adverse reactions following use of both drugs', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Artemether/Lumefantrine suspension', 'P. falciparum malaria', 'children', 'uncomplicated Plasmodium falciparum malaria'], 'conditions': ['Malaria, Falciparum']}, 'referencesModule': {'references': [{'pmid': '33289099', 'type': 'DERIVED', 'citation': 'Belard S, Ramharter M, Kurth F. Paediatric formulations of artemisinin-based combination therapies for treating uncomplicated malaria in children. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD009568. doi: 10.1002/14651858.CD009568.pub2.'}, {'pmid': '19102746', 'type': 'DERIVED', 'citation': 'Juma EA, Obonyo CO, Akhwale WS, Ogutu BR. A randomized, open-label, comparative efficacy trial of artemether-lumefantrine suspension versus artemether-lumefantrine tablets for treatment of uncomplicated Plasmodium falciparum malaria in children in western Kenya. Malar J. 2008 Dec 22;7:262. doi: 10.1186/1475-2875-7-262.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and efficacy in children aged 6 - 59 months with uncomplicated malaria, treated with either conventional artemether/lumefantrine tablets(Coartem®) or artemether/ lumefantrine suspension (Co-artesiane®) in Western Kenya'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged between 6 and 59 months\n* Minimum body weight of 5kg\n* Presence of fever (Temp \\>/= 37.5°C) or a history of fever in the last 24 hours\n* Presence of asexual P. falciparum monoinfection\n* Initial parasite density of between 2,000 and 200,000 asexual parasites/µl of blood\n* Not suffering from severe and complicated forms of malaria\n* Able to take drugs under study by the oral route\n* Parent or guardian gives informed written consent to participate in study\n\nExclusion Criteria:\n\n* Severe and/or complicated malaria (WHO, 2000 classification), including severe anaemia (Hb =/\\<5 g/dl), two or more seizures in last 24 hrs and hyper-parasitaemia (\\>200,000 µl)\n* Patients treated with mefloquine, halofantrine within the 7 days before Day 0 or with quinine salts and artemisinin derivatives within 3 days before Day 0, or artemether-lumefantrine 30 days before Day 0\n* Patients who require intensive care for malaria or another severe concomitant illness capable of interfering with the clinical evolution of malaria\n* Patients with vomiting and/or diarrhoea\n* Signs of severe malnutrition (defined as follows: children with weight/height ratio below 3 standard deviations or below 70% of the median of the WHO standardized reference values, or still with symmetrical oedema affecting both feet)\n* Presence of general danger signs in children below 5 years or other signs of serious and complex Plasmodium falciparum, as stated in the present WHO definitions\n* Patients with known history of heart disease or arrhythmia\n* History of allergy to artemether/lumefantrine or quinine'}, 'identificationModule': {'nctId': 'NCT00529867', 'briefTitle': 'Randomised Efficacy Study of Two Artemether-Lumefantrine Oral Formulations for the Treatment of Uncomplicated P. Falciparum Malaria', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dafra Pharma'}, 'officialTitle': 'A Randomized Open-Label Trial of the Efficacy of Artemether-Lumefantrine Suspension Compared With Artemether-Lumefantrine Tablets for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Less Than Five Years in Western Kenya', 'orgStudyIdInfo': {'id': 'SSC protocol No. 1210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: Artemether/lumefantrine tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: Artemether/Lumefantrine suspension']}], 'interventions': [{'name': 'Artemether/lumefantrine tablets', 'type': 'DRUG', 'otherNames': ['Coartem'], 'description': 'Artemether/lumefantrine tablets containing 20mg artemether and 120mg lumefantrine\n\nDosage: 5 - 14.9 kg: 1 tablet and 15 - 24.9 kg: 2 tablets\n\nAdministered at 0, 8, 24, 36, 48, and 60 hours on days 0, 1, and 2', 'armGroupLabels': ['A']}, {'name': 'Artemether/Lumefantrine suspension', 'type': 'DRUG', 'otherNames': ['Co-Artesiane suspension'], 'description': 'Artemether/lumefantrine suspension containing 15mg artemether and 90mg lumefantrine per 5ml suspension\n\nDosage: 5.0 - 7.4 kg = 7 ml, 7.5 - 9.9 kg = 10 ml, 10 - 12.4 kg = 14 ml, 12.5 - 14.9 kg = 17 ml, 15 - 17.4 kg = 20 ml, 17.5 - 19.9 kg = 24 ml, 20 - 22.4 kg = 27 ml and 22.5 - 24.9 kg = 30 ml\n\nAdministered once daily at 0, 24, and 48 hours on days 0, 1 and 2', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40100', 'city': 'Kisumu', 'state': 'Nyanza', 'country': 'Kenya', 'facility': 'Chulaimbo Health Centre', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}], 'overallOfficials': [{'name': 'Elizabeth A Juma, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kenya Medical Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dafra Pharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kenya Medical Research Institute', 'class': 'OTHER'}]}}}