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 determine the efficacy of sulfadoxine-pyrimethamine plus artesunate versus sulfadoxine-pyrimethamine alone in the treatment of uncomplicated malaria.
Detailed Description
Resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to the control of malaria. In order to facilitate formulation of effective regional drug policies and to provide a da...
Eligibility Criteria
Inclusion
- Male or female, older than 12 months.
- Weight \> 10 kg.
- Diagnoses of pure uncomplicated acute P. falciparum malaria parasitaemia of up to 500 000 asexual parasite/mcl blood with axillary temperature of greater than or equal to 37.5°C or history of fever (defined as within the previous 24 hours).
- Documented informed consent.
- Lives close enough to the study site for reliable follow up.
Exclusion
- Has received anti-malarial treatment in the past 7 days.
- Is infected with other malarial species (such subjects may be excluded retrospectively from the analysis).
- 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) or other danger signs.
- Has received cotrimoxazole, trimethoprim, chloramphenicol, folate or tetracyclines (including doxycycline) in the past 7 days or is likely to require these during the study period.
- History of G6PD deficiency.
- 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. co-artemether).
- Serious underlying disease that in the opinion of the clinic team and/or Principal Investigator would make the patient unsuitable for the study in terms of their safety or study analysis.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00203814
Start Date
January 1 2004
End Date
March 1 2005
Last Update
November 16 2006
Active Locations (2)
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1
Boane Clinic
Boane, Maputo Province, Mozambique
2
Magude Clinic
Magude, Mozambique