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Sponsored by: |
Dafra Pharma |
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Information provided by: | Dafra Pharma |
ClinicalTrials.gov Identifier: | NCT00484900 |
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.
Condition | Intervention | Phase |
---|---|---|
Plasmodium Falciparum Malaria |
Drug: Co-Arinate FDC Drug: Coartem |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 1390 |
Study Start Date: | May 2006 |
Study Completion Date: | May 2007 |
Ages Eligible for Study: | 6 Months and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Cameroon | |
Cameroon Baptist Convention Clinic of Biyem-Assi | |
Yaounde, Cameroon | |
Mali | |
Health centres of Samako, Kolle and Bancoumane | |
Bamako, Mali | |
Rwanda | |
Health centres Rwamagana and Muhima | |
Kigali, Rwanda | |
Sudan | |
Alhara Alola Health centre | |
New Halfa, Sudan |
Principal Investigator: | Issaka Sagara, Dr | University of Bamako, Mali |
Principal Investigator: | Wilfred F Mbacham, Dr | University Yaoundé, Cameroon |
Principal Investigator: | Ishag A Adam, Dr | University of Khartoum, Sudan |
Principal Investigator: | Stephen Rulisa, Dr | Kigali Central University Hospital, Rwanda |
Study ID Numbers: | 2005/57/01 |
Study First Received: | June 8, 2007 |
Last Updated: | March 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00484900 |
Health Authority: | Mali: Ministry of Health |
Open randomized multi-centre clinical trial in Africa Uncomplicated P. falciparum malaria Artemisinin-based Combination Therapy |
Artesunate + sulfalene + pyrimethamine 24 hour treatment Artemether + lumefantrine |
Pyrimethamine Artesunate Benflumetol Protozoan Infections Artemether-lumefantrine combination Artemisinine Malaria |
Malaria, Falciparum Artemether Folic Acid Artemisinins Sulfalene Parasitic Diseases |
Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis Enzyme Inhibitors Anti-Infective Agents, Urinary Folic Acid Antagonists |
Renal Agents Pharmacologic Actions Antimalarials Antiparasitic Agents Therapeutic Uses Amebicides |