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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00289250
First Posted: February 9, 2006
Last Update Posted: March 1, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medical Research Council Unit, The Gambia
Information provided by:
London School of Hygiene and Tropical Medicine
  Purpose
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.

Condition Intervention Phase
Asymptomatic P.Falciparum Malaria Drug: Sulfadoxine-pyrimethamine Drug: Sulfadoxine-pyrimethamine plus artesunate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

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

Estimated Enrollment: 360
Study Start Date: May 2001
Estimated Study Completion Date: December 2001
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289250


Locations
Gambia
Medical Reseearch Council Laboratories The Gambia
Banjul, Gambia, POBOX 273
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Medical Research Council Unit, The Gambia
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
  More Information

ClinicalTrials.gov Identifier: NCT00289250     History of Changes
Other Study ID Numbers: SCC867
First Submitted: February 8, 2006
First Posted: February 9, 2006
Last Update Posted: March 1, 2006
Last Verified: December 2002

Keywords provided by London School of Hygiene and Tropical Medicine:
Malaria
Gametocytes
Asymptomatic carriers

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artesunate
Pyrimethamine
Sulfadoxine
Fanasil, pyrimethamine drug combination
Antimalarials
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents