Comparative Evaluation of the Safety and the Efficacy of Artemether + Lumefantrine (Coartem™) vs. Sulfadoxine + Pyrimethamine (SP) in Both HIV+ and HIV- Adults With Uncomplicated P. Falciparum Malaria in Zambia
| Registry | NCT00304980 |
|---|---|
| Status | Terminated |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 3000 |
| Sponsor | Institute of Tropical Medicine, Belgium (Other) |
| Conditions | Plasmodium Falciparum Malaria |
| Interventions | ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE (Drug) |
| Dates | start 2003-03-01, completion 2005-04-01, first posted 2006-03-21, last updated 2010-09-14 |
| Locations | 1 site in Zambia |
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All trials for Plasmodium Falciparum Malaria All trials of ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE
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.
Sex: All, ages: 15 Years to 45 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Tropical Disease Research Center | Ndola, Cupperbelt | Zambia |