Comparative Evaluation of the Safety and the Efficacy of 2 Antimalarials Depending on HIV Status
Not Applicable
Terminated
- Conditions
- Plasmodium Falciparum Malaria
- Registration Number
- NCT00304980
- Lead Sponsor
- Institute of Tropical Medicine, Belgium
- Brief Summary
The purpose of this study is to determine the safety and efficacy of sulfadoxine-pyrimethamine (SP) versus artemether-lumefantrine (Coartem) when administered to HIV+ and HIV- patients with uncomplicated P. falciparum malaria. Patients will be randomised to one of the 2 treatment and followed up (until day 14 actively) for 45 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3000
Inclusion Criteria
- Man and non-pregnant women aged between 15 and 50.
- P.falciparum mono-infection of at least 1,000 parasites/µl.
- Body temperature ≥ 37.5°C at the moment of enrolment or history of fever in the preceding 48 hrs.
- Consent from patient obtained.
Exclusion Criteria
- Pregnancy.
- Severe P. falciparum malaria .
- Documented intake of SP or Coartem two weeks or less prior recruitment.
- Other cause(s) of fever.
- Evidence of underlying chronic diseases (cardiac, renal, hepatic, malnutrition).
- History of allergy to study drug, or known allergy to other Sulphur drugs such as co-trimoxazol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method PCR corrected clinical and parasitological outcome at day 45
- Secondary Outcome Measures
Name Time Method Tolerability Clinical recovery
Trial Locations
- Locations (1)
Tropical Disease Research Center
🇿🇲Ndola, Cupperbelt, Zambia