Status:
COMPLETED
A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria
Lead Sponsor:
University of Cape Town
Collaborating Sponsors:
World Health Organization
Medical Research Council, South Africa
Conditions:
Malaria
Eligibility:
All Genders
12+ years
Phase:
NA
Brief 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 eval...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2003
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00203736
Start Date
January 1 2003
End Date
October 1 2003
Last Update
November 16 2006
Active Locations (2)
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1
Catuane Clinic
Catuane, Matutuine, Mozambique
2
Namaacha Clinic
Namaacha, Namaacha, Mozambique