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

This study has been completed.
Sponsor:
Collaborator:
Medical Research Council Unit, The Gambia
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00289250
First received: February 8, 2006
Last updated: February 28, 2006
Last verified: December 2002
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00289250     History of Changes
Other Study ID Numbers: SCC867
Study First Received: February 8, 2006
Last Updated: February 28, 2006
Health Authority: Gambia: Department of State for Health and Social Welfare

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
Antimalarials
Pyrimethamine
Sulfadoxine
Artesunate
Fanasil, pyrimethamine drug combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Amebicides

ClinicalTrials.gov processed this record on August 19, 2014