Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2026-01-01 @ 5:24 AM
Study NCT ID:
NCT00484900
Status:
COMPLETED
Last Update Posted:
2008-03-26
First Post:
2007-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments on 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': '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-25', 'studyFirstSubmitDate': '2007-06-08', 'studyFirstSubmitQcDate': '2007-06-08', 'lastUpdatePostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PCR corrected Adequate Clinical and Parasitological Response', 'timeFrame': 'on day 28 (follow-up period)'}, {'measure': 'Early treatment failure', 'timeFrame': 'between day 0 and day 3'}, {'measure': 'Late clinical failure', 'timeFrame': 'between day 4 and day 28'}, {'measure': 'Late parasitological failure', 'timeFrame': 'between day 7 and day 28'}], 'secondaryOutcomes': [{'measure': 'Parasitic clearance', 'timeFrame': '28 day follow-up period'}, {'measure': 'Fever clearance', 'timeFrame': '28 day follow-up period'}, {'measure': 'Parasitological re-infection', 'timeFrame': '28 day follow-up period'}, {'measure': 'Gametocyte carriage', 'timeFrame': '28 day follow-up period'}, {'measure': 'Safety - Adverse events', 'timeFrame': '28 day follow-up period'}, {'measure': 'Haemoglobin levels', 'timeFrame': '28 day follow-up period'}, {'measure': 'Clinical and biological tolerance (Haemogram + Lever tests)', 'timeFrame': '28 day follow-up period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Open randomized multi-centre clinical trial in Africa', 'Uncomplicated P. falciparum malaria', 'Artemisinin-based Combination Therapy', 'Artesunate + sulfalene + pyrimethamine', '24 hour treatment', 'Artemether + lumefantrine'], 'conditions': ['Plasmodium Falciparum Malaria']}, 'referencesModule': {'references': [{'pmid': '19366448', 'type': 'DERIVED', 'citation': 'Sagara I, Rulisa S, Mbacham W, Adam I, Sissoko K, Maiga H, Traore OB, Dara N, Dicko YT, Dicko A, Djimde A, Jansen FH, Doumbo OK. Efficacy and safety of a fixed dose artesunate-sulphamethoxypyrazine-pyrimethamine compared to artemether-lumefantrine for the treatment of uncomplicated falciparum malaria across Africa: a randomized multi-centre trial. Malar J. 2009 Apr 14;8:63. doi: 10.1186/1475-2875-8-63.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this open randomised multi-centre clinical trial is to test the hypothesis that three pills of the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine, administered over 24 hours is not inferior in efficacy to the same drug administered over 48 hours and that the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine As/SMP fdc, independently of the duration of its dose interval, is not inferior in efficacy to 6 - 24 pills (number of pills administered to respectively children and adults)of the 60 hours treatment of artemether/lumefantrine for the treatment of uncomplicated P. falciparum malaria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age at least 6 months,\n* weight at least 5 kg,\n* residing in one of the four countries (Mali, Cameroon, Sudan, Rwanda),\n* able to receive oral treatment,\n* having an axillary body temperature of more than 37,5 degrees Celsius or history of fever within the proceeding 24 hours,\n* suffering from a mono specific P. falciparum infection with a parasite density between 2000 and 200000 asexual forms per micro litre of blood.\n\nExclusion Criteria:\n\n* presence of severe or complicated malaria (WHO 2000),\n* severe concomitant pathology or one that needs a medical follow-up incompatible with the study,\n* allergic to one of the drugs involved in this study,\n* pregnant (reported pregnancy, detected clinically or with the β HCG test),\n* use of one of the anti-malaria drugs involved in this study during 28 days preceding inclusion.'}, 'identificationModule': {'nctId': 'NCT00484900', 'briefTitle': 'Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments on P. Falciparum Malaria', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dafra Pharma'}, 'officialTitle': 'Open Randomized Multi-Centre Trial, Comparing Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 3 Days, Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 48 Hours and Artemether-Lumefantrine FDC Over 3 Days on P. Falciparum Malaria', 'orgStudyIdInfo': {'id': '2005/57/01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Co-Arinate FDC', 'type': 'DRUG'}, {'name': 'Coartem', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yaoundé', 'country': 'Cameroon', 'facility': 'Cameroon Baptist Convention Clinic of Biyem-Assi', 'geoPoint': {'lat': 3.86667, 'lon': 11.51667}}, {'city': 'Bamako', 'country': 'Mali', 'facility': 'Health centres of Samako, Kolle and Bancoumane', 'geoPoint': {'lat': 12.60915, 'lon': -7.97522}}, {'city': 'Kigali', 'country': 'Rwanda', 'facility': 'Health centres Rwamagana and Muhima', 'geoPoint': {'lat': -1.94995, 'lon': 30.05885}}, {'city': 'New Halfa', 'country': 'Sudan', 'facility': 'Alhara Alola Health centre', 'geoPoint': {'lat': 15.33021, 'lon': 35.59854}}], 'overallOfficials': [{'name': 'Issaka Sagara, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bamako, Mali'}, {'name': 'Wilfred F Mbacham, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Yaoundé, Cameroon'}, {'name': 'Ishag A Adam, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Khartoum, Sudan'}, {'name': 'Stephen Rulisa, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kigali Central University Hospital, Rwanda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dafra Pharma', 'class': 'INDUSTRY'}}}}