NCT00203801

Combination Antimalarials in Uncomplicated Malaria

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (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 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.

Detailed description

The resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to the control of malaria. In the South East African Combination Anti-malarial Therapy (SEACAT) evaluation, there will be a comprehensive evaluation of phased introduction of combination anti-malarials (CAT) in Mozambique, Swaziland and South Africa. In order to facilitate formulation of an effective regional drug policy and provide a database for decision-making on the implementation of combination therapy, it is essential that the in vivo response to CAT in all three countries be investigated. An SP therapeutic efficacy study will be conducted according to this modified World Health Organization (WHO) protocol to guide the selection of CAT. After CAT is introduced an in vivo CAT efficacy study will then be conducted to evaluate the efficacy of artesunate plus SP (or artemether-lumefantrine in KwaZulu Natal and Limpopo). In areas of low intensity malaria transmission the CAT in vivo study results will be compared across sites and with those found at baseline with monotherapy, for each site.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	Sulfadoxine-pyrimethamine
DRUG	Artesunate plus sulfadoxine-pyrimethamine
DRUG	Artemether-lumefantrine

Timeline

• Start date: 2002-01-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2005-09-20
• Last updated: 2018-10-19

Locations

7 sites across 3 countries: Eswatini, Mozambique, South Africa