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.
Sponsor study identifier
interventional
280
1 country
2
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
March 2005
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2005
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
March 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 13, 2005
Actual (reported)September 20, 2005
Actual (reported)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 GLURP and MSP I & II markers
Parasite clearance time
Fever clearance time
Association between study treatment and gametocyte carriage
Pharmacokinetics by measurement of whole blood levels of Sulfadoxine and Pyrimethamine
Correlation of the frequency of DHFR and DHPS mutations with parasitological outcome
Tolerability by describing adverse events and changes in haematological parameters
Capacity building by describing the training and development of study teams and their subsequent skills attained
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Artesunate plus sulfadoxine-pyrimethamine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordBoane Clinic
Boane, Maputo Province, Mozambique
Magude Clinic
Magude, Mozambique
Allen EN, Little F, Camba T, Cassam Y, Raman J, Boulle A, Barnes KI. Efficacy of sulphadoxine-pyrimethamine with or without artesunate for the treatment of uncomplicated Plasmodium falciparum malaria in southern Mozambique: a randomized controlled trial. Malar J. 2009 Jun 26;8:141. doi: 10.1186/1475-2875-8-141.
Karen Barnes, MBChB
University of Cape Town
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
March 2005
Date type not reportedContact the study team to confirm eligibility.
This date has not been verified as actual or estimated.
Last Updated
November 16, 2006
Record last verified: 2005-08
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Source: ClinicalTrials.gov.
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