Early Childhood Malaria Prevention With Maloprim in The Gambia

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

Study Overview

• Status: Completed
• Conditions: Malaria
• Intervention / Treatment: Drug: Maloprim

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

• Study Type: Interventional
• Enrollment: 2253
• Phase: Phase 4

Contacts and Locations

Study Locations

• Gambia
  • Central River Division
    • Farafenni, Central River Division, Gambia
      • Medical Research Council Field Station

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 4 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: London School of Hygiene and Tropical Medicine; Wellcome Trust; Medical Research Council Unit, The Gambia; Government of the Gambia; Partnership for Child Development
• Investigators: Principal Investigator: Brian M Greenwood, MD, London School of Hygiene and Tropical Medicine; Principal Investigator: Matthew CH Jukes, DPhil, Imperial College London

Publications and helpful links

General Publications

• Greenwood BM, Greenwood AM, Bradley AK, Snow RW, Byass P, Hayes RJ, N'Jie AB. Comparison of two strategies for control of malaria within a primary health care programme in the Gambia. Lancet. 1988 May 21;1(8595):1121-7. doi: 10.1016/s0140-6736(88)91949-6.
• Menon A, Snow RW, Byass P, Greenwood BM, Hayes RJ, N'Jie AB. Sustained protection against mortality and morbidity from malaria in rural Gambian children by chemoprophylaxis given by village health workers. Trans R Soc Trop Med Hyg. 1990 Nov-Dec;84(6):768-72. doi: 10.1016/0035-9203(90)90071-l.
• Greenwood BM, David PH, Otoo-Forbes LN, Allen SJ, Alonso PL, Armstrong Schellenberg JR, Byass P, Hurwitz M, Menon A, Snow RW. Mortality and morbidity from malaria after stopping malaria chemoprophylaxis. Trans R Soc Trop Med Hyg. 1995 Nov-Dec;89(6):629-33. doi: 10.1016/0035-9203(95)90419-0.

Study record dates

Study Major Dates

• Study Start: April 1, 1982
• Study Completion: September 1, 2001

Study Registration Dates

• First Submitted: February 20, 2006
• First Submitted That Met QC Criteria: February 20, 2006
• First Posted (Estimated): February 22, 2006

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Children; Malaria; Anemia; Cognition; Mortality; Education; Chemoprophylaxis; Long-term effects; Prevention & control; The Gambia; Africa, West
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Maloprim
• Other Study ID Numbers: SCC-795-835