An interventional study of Sulfadoxine-pyrimethamine and Artesunate plus sulfadoxine-pyrimethamine in Malaria, sponsored by University of Cape Town. Completed at 2 sites in Mozambique. Open to participants aged 12 Months and older. Per ClinicalTrials.gov, last updated 2006-11-16.
Sponsored by University of Cape Town · Not applicable, Interventional, and Treatment
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.
Resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to malaria control. In the South East African Combination Anti-malarial Therapy (SEACAT) evaluation, there is an evaluation of the phased introduction of combination anti-malarial therapy (CAT) in Mozambique, Swaziland and South Africa. In order to facilitate formulation of effective regional drug policy and provide a database for decision-making on the implementation of CAT, it is essential that the in vivo response to CAT be investigated. This will be achieved through the SEACAT 01 protocol which is a component of the SEACAT evaluation described in another file on this website. However, in selected Mozambique sites where the intensity of malaria transmission is high, a direct parallel group comparison of monotherapy (SP) with CAT (artesunate, AS, plus SP) will be conducted according to a specific amendment (Amendment 4) to the SEACAT 01 protocol. Amendment 4 is presented in this separate file on the website for clarity.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 240 is close to the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →University of Cape Town is the lead sponsor of 109 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
This study is completed, as verified in Aug 2005. You cannot join it, but the record below documents what was studied.
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University of Cape Town