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Sponsors and Collaborators: |
University of Cape Town World Health Organization Medical Research Council, South Africa |
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Information provided by: | University of Cape Town |
ClinicalTrials.gov Identifier: | NCT00203814 |
The purpose of this study is to determine the efficacy of sulfadoxine-pyrimethamine plus artesunate versus sulfadoxine-pyrimethamine alone in the treatment of uncomplicated malaria.
Condition | Intervention |
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Malaria |
Drug: Sulfadoxine-pyrimethamine Drug: Artesunate plus sulfadoxine-pyrimethamine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Open-Label, Randomised, Parallel Group in Vivo Drug Study to Evaluate Combination Anti-Malarial Therapy (CAT), Artesunate and Sulfadoxine-Pyrimethamine Versus Sulfadoxine-Pyrimethamine Alone, in Terms of Therapeutic Efficacy, Prevalence of Gametocyte Carriage and Prevalence of Molecular Markers Associated With SP Resistance In Uncomplicated Plasmodium Falciparum Infections. |
Estimated Enrollment: | 280 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | March 2005 |
Resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to the control of malaria. In order to facilitate formulation of effective regional drug policies and to provide a database for decision-making on the implementation of combination therapy (CAT), it is essential that the in vivo response to CAT be investigated. In the South East African Combination Anti-malarial Therapy (SEACAT) evaluation, there is a comprehensive evaluation of the phased introduction of combination anti-malarial therapy in Mozambique. As a component of this evaluation, in selected Mozambique sites where intensity of malaria transmission is high, a direct parallel group comparison of monotherapy (SP) with CAT (artesunate plus SP) will be conducted according to this protocol.
Ages Eligible for Study: | 12 Months and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
co-artemether).
Mozambique | |
Magude Clinic | |
Magude, Mozambique | |
Mozambique, Maputo | |
Boane Clinic | |
Boane, Maputo, Mozambique |
Principal Investigator: | Karen Barnes, MBChB | University of Cape Town |
Study ID Numbers: | SEACAT 01a ASSP |
Study First Received: | September 13, 2005 |
Last Updated: | November 15, 2006 |
ClinicalTrials.gov Identifier: | NCT00203814 History of Changes |
Health Authority: | Mozambique: Ministry of Health (MISAU) |
Malaria Efficacy Pharmacokinetic Gametocyte |
Molecular markers Sulfadoxine-pyrimethamine Artesunate Artemisinin |
Pyrimethamine Artesunate Protozoan Infections Sulfadoxine-pyrimethamine Artemisinine Malaria Anti-Infective Agents, Urinary |
Sulfadoxine Folic Acid Antagonists Folic Acid Antimalarials Artemisinins Parasitic Diseases |
Pyrimethamine Artesunate Protozoan Infections Anti-Infective Agents Sulfadoxine-pyrimethamine Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis Anti-Infective Agents, Urinary Enzyme Inhibitors |
Malaria Renal Agents Folic Acid Antagonists Sulfadoxine Pharmacologic Actions Antimalarials Antiparasitic Agents Therapeutic Uses Parasitic Diseases Amebicides |