Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum
- Conditions
- Asymptomatic P.Falciparum Malaria
- Registration Number
- NCT00289250
- Lead Sponsor
- London School of Hygiene and Tropical Medicine
- Brief Summary
Treatment of uncomplicated P.falciparum malaria with sulfadoxine-pyrimethamine (SP) is followed by a marked increase in the density of gametocytes. To determine whether treatment with SP enhances gametocyte carriage, we randomized asymptomatic carriers of P.falciparum to receive SP alone, SP with a single dose of artesunate, or placebo, and followed them for 56 days to record gametocyte presence and density.
- Detailed Description
Treatment of P. falciparum malaria with sulfadoxine-pyrimethamine (SP) is followed by a sharp rise in the density of gametocytes. Drug-induced release could enhance transmission of resistant parasites and would argue against the use of SP, especially for intermittent preventive treatment (IPT). We did a randomized trial to determine the effect of treatment with SP on gametocyte carriage. The trial is a three-arm open-label randomized trial. We randomized asymptomatic carriers of P.falciparum to receive antimalarial treatment or placebo, and recorded the prevalence and density of gametocytes over the next 2 months. The trial was conducted during the dry (low malaria transmission) season in four rural villages in The Gambia. Adults and children aged over 6 months who had asexual P.falciparum infection and were confirmed to be free of clinical symptoms of malaria over a 2-day screening period were enrolled and randomized to receive a single dose of SP, or SP plus a single dose of artesunate (SP+AS), or placebo. The primary endpoints were presence of gametocytes 7 and 56 days after treatment, and the duration and density of gametocytaemia over 2 months measured by the area under the curve of gametocyte density against time.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
- P.falciparum parasitaemia above 20/uL
- Resident in one of the four study villages
- Fever
- Any other sign of clinical malaria
- Pregnancy
- Weight <5kg
- History of hypersensitivity to any of the study drugs
- Treatment with any of the study drugs in the last 4 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Presence of gametocytes 7 days after treatment
- Secondary Outcome Measures
Name Time Method Presence of gametocytes 56 days after treatment Asexual parasitaemia 14 days after treatment
Trial Locations
- Locations (1)
Medical Reseearch Council Laboratories The Gambia
🇬🇲Banjul, Gambia