Open Label Drug Study (With Single and Parallel Group Components) to Evaluate Combination Antimalarial Therapy for Efficacy, Gametocyte Carriage and Molecular Markers Associated With SP Resistance in Uncomplicated Plasmodium Falciparum Infections
Sponsor study identifier
interventional
240
1 country
2
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
October 2003
Date type not reportedThis date has not been verified as actual or estimated.
The purpose of this study is to compare the efficacy of sulfadoxine-pyrimethamine plus artesunate with that of sulfadoxine-pyrimethamine on its own for the treatment of uncomplicated malaria.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2003
Date type not reportedThis date has not been verified as actual or estimated.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
October 2003
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 frequency of DHFR and DHPS mutations with parasitological outcome
Tolerability by describing adverse events and changes in haematological parameters
Capacity by describing the training and development of study teams
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 recordCatuane Clinic
Catuane, Matutuine, Mozambique
Namaacha Clinic
Namaacha, Namaacha, 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 2003
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
October 2003
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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