Trials / Completed
CompletedNCT00203736
A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 240 (planned)
- Sponsor
- University of Cape Town · Academic / Other
- Sex
- All
- Age
- 12 Months
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sulfadoxine-pyrimethamine | |
| DRUG | Artesunate plus sulfadoxine-pyrimethamine |
Timeline
- Start date
- 2003-01-01
- Completion
- 2003-10-01
- First posted
- 2005-09-20
- Last updated
- 2006-11-16
Locations
2 sites across 1 country: Mozambique
Source: ClinicalTrials.gov record NCT00203736. Inclusion in this directory is not an endorsement.