Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum
February 28, 2006 updated by: London School of Hygiene and Tropical Medicine
Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum: A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
360
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Banjul, Gambia, POBOX 273
- Medical Reseearch Council Laboratories The Gambia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Presence of gametocytes 7 days after treatment
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Secondary Outcome Measures
Outcome Measure |
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Presence of gametocytes 56 days after treatment
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Asexual parasitaemia 14 days after treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Margaret Pinder, PhD, Medical Research Council Unit, The Gambia
- Study Chair: Paul J Milligan, PhD, London School of Hygiene and Tropical Medicine
- Principal Investigator: Sam K Dunyo, PhD, Medical Research Council Unit, The Gambia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2001
Study Completion
December 1, 2001
Study Registration Dates
First Submitted
February 8, 2006
First Submitted That Met QC Criteria
February 8, 2006
First Posted (Estimate)
February 9, 2006
Study Record Updates
Last Update Posted (Estimate)
March 1, 2006
Last Update Submitted That Met QC Criteria
February 28, 2006
Last Verified
December 1, 2002
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Malaria, Falciparum
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Anthelmintics
- Folic Acid Antagonists
- Schistosomicides
- Antiplatyhelmintic Agents
- Anti-Infective Agents, Urinary
- Renal Agents
- Pyrimethamine
- Artesunate
- Sulfadoxine
- Fanasil, pyrimethamine drug combination
Other Study ID Numbers
- SCC867
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.