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Sponsors and Collaborators: |
University of Cape Town World Health Organization Medical Research Council, South Africa Global Fund |
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Information provided by: | University of Cape Town |
ClinicalTrials.gov Identifier: | NCT00203801 |
The purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own and compare this with efficacy of a new combination antimalarial therapy, either sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine.
Condition | Intervention |
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Malaria |
Drug: Sulfadoxine-pyrimethamine Drug: Artesunate plus sulfadoxine-pyrimethamine Drug: Artemether-lumefantrine |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
Official Title: | An Open Label In Vivo Drug Study to Evaluate Combination Anti-Malarial Therapy (CAT),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: | 700 |
Study Start Date: | January 2002 |
Estimated Study Completion Date: | July 2005 |
The resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to the control of malaria.
In the South East African Combination Anti-malarial Therapy (SEACAT) evaluation, there will be a comprehensive evaluation of phased introduction of combination anti-malarials (CAT) in Mozambique, Swaziland and South Africa.
In order to facilitate formulation of an effective regional drug policy and provide a database for decision-making on the implementation of combination therapy, it is essential that the in vivo response to CAT in all three countries be investigated. An SP therapeutic efficacy study will be conducted according to this modified WHO protocol to guide the selection of CAT. After CAT is introduced an in vivo CAT efficacy study will then be conducted to evaluate the efficacy of artesunate plus SP (or artemether-lumefantrine in KwaZulu Natal and Limpopo). In areas of low intensity malaria transmission the CAT in vivo study results will be compared across sites and with those found at baseline with monotherapy, for each site.
Ages Eligible for Study: | 12 Months and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Mozambique | |
Namaacha Clinic | |
Namaacha, Mozambique | |
Mozambique, Matutuine | |
Bela Vista Clinic | |
Bela Vista, Matutuine, Mozambique | |
South Africa, KwaZulu Natal | |
Ndumo Clinic | |
Ndumo, KwaZulu Natal, South Africa | |
South Africa, Limpopo | |
Lulekani Clinic | |
Lulekani, Limpopo, South Africa | |
South Africa, Mpumalanga | |
Naas Clinic | |
Naas, Mpumalanga, South Africa | |
Swaziland | |
Vuvulane Clinic | |
Vuvulane, Swaziland | |
Ndzevane Clinic | |
Ndzevane, Swaziland |
Principal Investigator: | Karen Barnes, MBChB | University of Cape Town |
Study ID Numbers: | SEACAT 01 Mono (Am 1,2,3,5,6) |
Study First Received: | August 29, 2005 |
Last Updated: | September 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00203801 History of Changes |
Health Authority: | South Africa: Medicines Control Council; Mozambique: Ministry of Health; Swaziland: Ministry of Health and Social Welfare |
Malaria Efficacy Pharmacokinetic Gametocyte |
Molecular markers Sulfadoxine-pyrimethamine Artesunate Artemisinin |
Pyrimethamine Artesunate Benflumetol Protozoan Infections Anti-Infective Agents Sulfadoxine-pyrimethamine Artemisinine Folate Anthelmintics Anti-Infective Agents, Urinary Malaria |
Folinic Acid Folic Acid Antagonists Sulfadoxine Vitamin B9 Artemether Folic Acid Antimalarials Artemisinins Antifungal Agents Parasitic Diseases |
Benflumetol Pyrimethamine Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Malaria Renal Agents Artemether Antimalarials Antiparasitic Agents Antifungal Agents Therapeutic Uses Parasitic Diseases Amebicides |
Coccidiostats Artesunate Protozoan Infections Sulfadoxine-pyrimethamine Coccidiosis Antiplatyhelmintic Agents Enzyme Inhibitors Anti-Infective Agents, Urinary Anthelmintics Sulfadoxine Folic Acid Antagonists Schistosomicides Pharmacologic Actions |