Open Label Study to Evaluate Combination Anti-malarial Therapy,in Terms of Efficacy, Prevalence of Gametocyte Carriage and Molecular Markers Associated With Sulfadoxine Pyrimethamine Resistance in Uncomplicated Plasmodium Falciparum

NCT00203801 NA COMPLETED

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.

Details

Lead sponsor	University of Cape Town
Phase	NA
Status	COMPLETED
Enrolment	700
Start date	2002-01
Completion	2005-07

Conditions

• Malaria

Interventions

• Sulfadoxine-pyrimethamine
• Artesunate plus sulfadoxine-pyrimethamine
• Artemether-lumefantrine

Primary outcomes

• Therapeutic efficacy defined as:
• Adequate Clinical and Parasitological Response (ACPR), Early Treatment Failure (ETF), Late Treatment Failure (LTF), defined as Late Clinical Failure (LCF) and Late Parasitological Failure (LPF);
• Sensitive or parasitological failure (RI, early and late, RII, RIII)
• Parasitological failures will be classified as recrudescence or re-infection (or indeterminate) using glutamate-rich protein (GLURP) and merozoite surface protein (MSP) I & II markers;
• Parasite clearance time;
• Fever clearance time.

Countries

Eswatini, Mozambique, South Africa