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Completed

NCT Number: NCT00289250

Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum

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.

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Key information

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Reseearch Council Laboratories The Gambia

Banjul, POBOX 273, The Gambia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulfadoxine-Pyrimethamine

Drug

sulfadoxine-pyrimethamine plus artesunate

Drug

Primary outcomes

  1. Presence of gametocytes 7 days after treatment

Secondary outcomes

  1. Presence of gametocytes 56 days after treatment

  2. Asexual parasitaemia 14 days after treatment

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Medical Research Council Unit, The Gambia

Registry information

Official study title

Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum: A Randomized Controlled Trial

Important dates

Study start
2001
Study completion
2001
First posted
Feb 9, 2006
Registry last updated
Mar 1, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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