Plasmodium Falciparum Malaria
Conditions
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.
Interventions
DRUGARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE
Sponsors
Institute of Tropical Medicine, Belgium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCR corrected clinical and parasitological outcome at day 45 | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability | — |
| Clinical recovery | — |
Countries
Zambia
Outcome results
None listed