A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cape Town
• Collaborators: Global Fund; Medical Research Council, South Africa; World Health Organization
• Treatments: Antimalarials; Artesunate; Fanasil, pyrimethamine drug combination; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• Male or female, older than 12 months.

• Weight > 10 kg.

• Diagnoses of uncomplicated acute P. falciparum malaria parasitaemia of up to 500 000 asexual parasite/mcl blood with axillary temperature of greater than and equal to 37.50C or history of fever.

• Documented informed consent.

• Lives close enough to the health centre for reliable follow up.

Exclusion Criteria:

• Has received anti-malarial treatment in the past 7 days.

• Is infected with other malarial species (such subjects will be excluded retrospectively).

• Severely ill (based on WHO Criteria for severe malaria ) or if patient is considered, in the opinion of the investigator or designee, to have moderately severe malaria (e.g. prostrate, repeated vomiting, dehydrated).

• Has received cotrimoxazole or chloramphenicol in the past 7 days.

• History of G6PD deficiency.

• Is pregnant.

• Has a history of allergy to any sulphonamide (for SP) or artemisinin derivative (for artesunate and co-artemether).