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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00289250
Enrollment
360
Registered
2006-02-09
Start date
2001-05-31
Completion date
2001-12-31
Last updated
2006-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic P.Falciparum Malaria

Keywords

Malaria, Gametocytes, Asymptomatic carriers

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.

Interventions

DRUGSulfadoxine-pyrimethamine

Sponsors

Medical Research Council Unit, The Gambia
CollaboratorOTHER
London School of Hygiene and Tropical Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Presence of gametocytes 7 days after treatment

Secondary

MeasureTime frame
Presence of gametocytes 56 days after treatment
Asexual parasitaemia 14 days after treatment

Countries

The Gambia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026