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Completed

NCT Number: NCT00294580

Early Childhood Malaria Prevention With Maloprim in The Gambia

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

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Key information

Age range

3 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical Research Council Field Station

Farafenni, Central River Division, The Gambia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maloprim

Drug

Primary outcomes

  1. Mortality

  2. Episodes of Fever Associated with Malaria Parasitaemia

  3. Cognitive Abilities in late adolescence

  4. Educational Attainment (Years spent at school)

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Government of the Gambia
  • London School of Hygiene and Tropical Medicine
  • Medical Research Council Unit, The Gambia
  • Partnership for Child Development
  • Wellcome Trust

Registry information

Official study title

Comparison of Two Strategies for Control of Malaria Within A Primary Health Care Programme in the Gambia

Important dates

Study start
1982
Study completion
2001
First posted
Feb 22, 2006
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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