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A Trial of Intermittent Treatment in the Prevention of Malaria in Senegalese Children
This study has been completed.
First Received: August 18, 2005   Last Updated: May 3, 2006   History of Changes
Sponsor: Gates Malaria Partnership
Collaborators: IRD, Dakar, Senegal.
IRD, Montpellier, France.
Cheikh Anta Diop University, Senegal
Ministry of Health, Senegal
Information provided by: Gates Malaria Partnership
ClinicalTrials.gov Identifier: NCT00132561
  Purpose

In countries of the Sahel and sub-Sahel, malaria transmission is highly seasonal with nearly all infections occurring during a few months of the year. However, mortality and morbidity from malaria may be high during this period, especially in young children who are the group most at risk.

Intermittent preventative treatment (IPT) is a new approach to the prevention of malaria in this situation. IPT involves the administration of an anti-malarial to children at risk for malaria at fixed times, even if they are not infected. To investigate how effective this approach might be in Senegal, a trial has been undertaken in which 1136 children aged 6 weeks to 59 months were given a single dose of sulfadoxine pyrimethamine and artesunate on three occasions during a three-month rainy season and the incidence of clinical malaria in these children was compared with that in a group of children who received placebo. Additional observations were made on the incidence of side effects in children in the two groups and on the impact of IPT in children (IPTc) on markers of drug resistance in children whose blood films were positive for Plasmodium falciparum.


Condition Intervention Phase
Malaria
Drug: Sulfadoxine/pyrimethamine and artesunate
Phase II
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: A Double-Blind, Randomised, Placebo-Controlled Trial to Measure the Potential of Intermittent Treatment With Artesunate Plus Sulphadoxine/Pyrimethamine (SP) to Reduce the Malaria Burden in Sub-Saharan Africa

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • Clinical episodes of malaria

Secondary Outcome Measures:
  • Side effects
  • Change in the prevalence of drug resistance markers

Estimated Enrollment: 1200
Study Start Date: June 2002
Estimated Study Completion Date: December 2003
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Weeks to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 6 weeks to 59 months
  • Residence in the study area
  • Informed consent

Exclusion Criteria:

  • Known allergy to study drugs
  • Serious underlying illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00132561

Locations
Senegal
Institut de recherche pour le developpement
Dakar, Senegal, BP 1386
Sponsors and Collaborators
Gates Malaria Partnership
IRD, Dakar, Senegal.
IRD, Montpellier, France.
Cheikh Anta Diop University, Senegal
Ministry of Health, Senegal
Investigators
Principal Investigator: Badara Cisse, MD IRD, Dakar, Senegal.
  More Information

Additional Information:
Publications:
Study ID Numbers: ITCR 5094
Study First Received: August 18, 2005
Last Updated: May 3, 2006
ClinicalTrials.gov Identifier: NCT00132561     History of Changes
Health Authority: Senegal: Ministere de la sante

Additional relevant MeSH terms:
Pyrimethamine
Artesunate
Protozoan Infections
Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Coccidiosis
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Malaria
Renal Agents
Folic Acid Antagonists
Sulfadoxine
Pharmacologic Actions
Antimalarials
Antiparasitic Agents
Therapeutic Uses
Parasitic Diseases
Amebicides

ClinicalTrials.gov processed this record on February 08, 2010