Clinical trial NCT00289250: Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum
Official title: Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asymptomatic P.Falciparum Malaria
Keywords: Malaria
Gametocytes
Asymptomatic carriers
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Medical Research Council Unit, The Gambia
First posted: 2006-02-09
Enrollment: 360
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* P.falciparum parasitaemia above 20/uL
* Resident in one of the four study villages

Exclusion Criteria:

* 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

Primary outcomes:
measure: Presence of gametocytes 7 days after treatment
Secondary outcomes:
measure: Presence of gametocytes 56 days after treatment
measure: Asexual parasitaemia 14 days after treatment
Other outcomes:
Locations:
city: Banjul
country: Gambia
facility: Medical Reseearch Council Laboratories The Gambia
Study officials:
affiliation: Medical Research Council Unit, The Gambia
name: Margaret Pinder, PhD
role: STUDY_DIRECTOR
affiliation: London School of Hygiene and Tropical Medicine
name: Paul J Milligan, PhD
role: STUDY_CHAIR
affiliation: Medical Research Council Unit, The Gambia
name: Sam K Dunyo, PhD
role: PRINCIPAL_INVESTIGATOR
References: