Status:
COMPLETED
Combination Antimalarials in 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 study the efficacy of sulfadoxine-pyrimethamine on its own and compare this with efficacy of a new combination antimalarial therapy, either sulphadoxine-pyrimethamine p...
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00203801
Start Date
January 1 2002
End Date
July 1 2005
Last Update
October 19 2018
Active Locations (7)
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1
Ndzevane Clinic
Ndzevane, Eswatini
2
Vuvulane Clinic
Vuvulane, Eswatini
3
Bela Vista Clinic
Bela Vista, Matutuine, Mozambique
4
Namaacha Clinic
Namaacha, Mozambique