Combination Antimalarials in Uncomplicated Malaria

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

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.

• 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: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Artesunate; Fanasil, pyrimethamine drug combination; Lumefantrine; 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 250 000 asexual parasite/mcl blood with axillary temperature of greater than and equal to 37.5 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.

• 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 Glucose-6-phosphate dehydrogenase (G6PD) deficiency (not a contra-indication for artemether-lumefantrine).

• Is pregnant or breastfeeding.

• Has a history of allergy to any of the study drugs (including other sulphonamides e.g. cotrimoxazole, other artemisinin derivatives e.g. artemether-lumefantrine).