Early Childhood Malaria Prevention With Maloprim in The Gambia

NCT ID: NCT00294580

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2253 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1982-04-30
• Study Completion Date: 2001-09-30

Brief Summary

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

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

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Maloprim

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical Research Council Unit, The Gambia

OTHER

Sponsor Role: collaborator

Government of the Gambia

UNKNOWN

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: collaborator

Partnership for Child Development

UNKNOWN

Sponsor Role: collaborator

Wellcome Trust

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Principal Investigators

Brian M Greenwood, MD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Matthew CH Jukes, DPhil

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Medical Research Council Field Station

Farafenni, Central River Division, The Gambia

Countries

The Gambia

References

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.

Reference Type: RESULT

PMID: 2896957 (View on PubMed)

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.

Reference Type: RESULT

PMID: 2096501 (View on PubMed)

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.

Reference Type: RESULT

PMID: 8594677 (View on PubMed)

Other Identifiers

SCC-795-835

Identifier Type: -

Identifier Source: org_study_id