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

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London School of Hygiene and Tropical Medicine

Status and phase

Completed
Phase 3

Conditions

Asymptomatic P.Falciparum Malaria

Treatments

Drug: Sulfadoxine-pyrimethamine
Drug: Sulfadoxine-pyrimethamine plus artesunate

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

6+ months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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