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

Primary Purpose

Asymptomatic P.Falciparum Malaria

Status
Completed
Phase
Phase 3
Locations
Gambia
Study Type
Interventional
Intervention
Sulfadoxine-pyrimethamine
Sulfadoxine-pyrimethamine plus artesunate
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asymptomatic P.Falciparum Malaria focused on measuring Malaria, Gametocytes, Asymptomatic carriers

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Medical Reseearch Council Laboratories The Gambia

Outcomes

Primary Outcome Measures

Presence of gametocytes 7 days after treatment

Secondary Outcome Measures

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

Full Information

First Posted
February 8, 2006
Last Updated
February 28, 2006
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Medical Research Council Unit, The Gambia
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1. Study Identification

Unique Protocol Identification Number
NCT00289250
Brief Title
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

2. Study Status

Record Verification Date
December 2002
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Medical Research Council Unit, The Gambia

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asymptomatic P.Falciparum Malaria
Keywords
Malaria, Gametocytes, Asymptomatic carriers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sulfadoxine-pyrimethamine
Intervention Type
Drug
Intervention Name(s)
Sulfadoxine-pyrimethamine plus artesunate
Primary Outcome Measure Information:
Title
Presence of gametocytes 7 days after treatment
Secondary Outcome Measure Information:
Title
Presence of gametocytes 56 days after treatment
Title
Asexual parasitaemia 14 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Pinder, PhD
Organizational Affiliation
Medical Research Council Unit, The Gambia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paul J Milligan, PhD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sam K Dunyo, PhD
Organizational Affiliation
Medical Research Council Unit, The Gambia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Reseearch Council Laboratories The Gambia
City
Banjul
ZIP/Postal Code
POBOX 273
Country
Gambia

12. IPD Sharing Statement

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

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