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Early Childhood Malaria Prevention With Maloprim in The Gambia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00294580
First Posted: February 22, 2006
Last Update Posted: May 28, 2015
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.
Collaborators:
Medical Research Council Unit, The Gambia
Government of the Gambia
London School of Hygiene and Tropical Medicine
Partnership for Child Development
Wellcome Trust
Information provided by:
Imperial College London
  Purpose
A trial was conducted in the 1980s to compare two strategies for control of malaria in young children aged 3-59 months: treatment with chloroquine versus treatment combined with fortnightly chemoprophylaxis with Maloprim. The impact on mortality and morbidity was assessed at the time, and their cognitive abilities and educational outcomes were assess 14 years later in 2001. The hypothesis was that the chemoprophylaxis would reduce morbidity and mortality and would improve cognitive abilities and educational outcomes in the long term

Condition Intervention Phase
Malaria Drug: Maloprim Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Comparison of Two Strategies for Control of Malaria Within A Primary Health Care Programme in the Gambia

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Mortality
  • Episodes of Fever Associated with Malaria Parasitaemia
  • Cognitive Abilities in late adolescence
  • Educational Attainment (Years spent at school)

Estimated Enrollment: 2253
Study Start Date: April 1982
Estimated Study Completion Date: September 2001
Detailed Description:

Two drug strategies for the control of malaria in children aged 3-59 months have been compared in a rural area of The Gambia - treatment of presumptive episodes of clinical malaria with chloroquine by village health workers, and treatment combined with fortnightly chemoprophylaxis (pyrimethamine/dapsone) which was also given by village health workers. Treatment alone did not have any significant effect on mortality or morbidity from malaria. In contrast, treatment and chemoprophylaxis reduced overall mortality in children aged 1-4 years, mortality from probable malaria, and episodes of fever associated with malaria parasitaemia. A high level of compliance with chemoprophylaxis was obtained and no harmful consequences of chemoprophylaxis were observed. Chemoprophylaxis was offered to all children at the end of the trial.

14 years after the end of the trial, participants cognitive abilities and educational attainment were assessed. Associations have been found between malaria infection and poor cognitive ability but causality has not yet been demonstrated through preventative trials and the long-term impact of malaria has not been investigated. 1190 children who had participated in the original trial for at least one year were targetted for follow-up. 579 were traced. Those who had received chemoprophylaxis attended school for 0.52 years more than the placebo group (p=.069). There was no overall effect on cognitive abilities but there was a significant treatment effect for cohorts that had not received chemoprophylaxis at the end of the trial or who had received less than one year of post-trial prophylaxis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • For original trial: Children aged 3-59 months present in participating villages
  • For follow-up: Children who were in original trial for at least 1 year.

Exclusion Criteria:

  • For original trial: None
  • For follow-up: Children with mental or physical disabilities who were unable to do cognitive tests
  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): NCT00294580


Locations
Gambia
Medical Research Council Field Station
Farafenni, Central River Division, Gambia
Sponsors and Collaborators
Imperial College London
Medical Research Council Unit, The Gambia
Government of the Gambia
London School of Hygiene and Tropical Medicine
Partnership for Child Development
Wellcome Trust
Investigators
Principal Investigator: Brian M Greenwood, MD London School of Hygiene and Tropical Medicine
Principal Investigator: Matthew CH Jukes, DPhil Imperial College London
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00294580     History of Changes
Other Study ID Numbers: SCC-795-835
First Submitted: February 20, 2006
First Posted: February 22, 2006
Last Update Posted: May 28, 2015
Last Verified: March 2006

Keywords provided by Imperial College London:
Malaria
Cognition
Prevention & control
Anemia
Chemoprophylaxis
Mortality
Children
Randomized controlled trial
Education
Long-term effects
The Gambia
Africa, West

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Maloprim
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents