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

NCT ID: NCT00289250

Last Updated: 2006-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2001-12-31

Brief Summary

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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

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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.

Conditions

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Asymptomatic P.Falciparum Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sulfadoxine-pyrimethamine

Intervention Type DRUG

Sulfadoxine-pyrimethamine plus artesunate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical Research Council Unit, The Gambia

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Principal Investigators

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Margaret Pinder, PhD

Role: STUDY_DIRECTOR

Medical Research Council Unit, The Gambia

Paul J Milligan, PhD

Role: STUDY_CHAIR

London School of Hygiene and Tropical Medicine

Sam K Dunyo, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Research Council Unit, The Gambia

Locations

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Medical Reseearch Council Laboratories The Gambia

Banjul, , The Gambia

Site Status

Countries

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The Gambia

Other Identifiers

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SCC867

Identifier Type: -

Identifier Source: org_study_id