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Early Childhood Malaria Prevention With Maloprim in The Gambia

This study has been completed.
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 Identifier:
First received: February 20, 2006
Last updated: May 27, 2015
Last verified: March 2006
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
Drug: Maloprim
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
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


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

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
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Please refer to this study by its identifier: NCT00294580

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
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: Identifier: NCT00294580     History of Changes
Other Study ID Numbers: SCC-795-835
Study First Received: February 20, 2006
Last Updated: May 27, 2015

Keywords provided by Imperial College London:
Prevention & control
Randomized controlled trial
Long-term effects
The Gambia
Africa, West

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents processed this record on May 24, 2017