Early Childhood Malaria Prevention With Maloprim in The Gambia

NCT00294580 | Completed Phase 4

• 1 other identifier: SCC-795-835
• Study Type: interventional
• Target: 2,253
• Locations: 1 country
• Sites: 1

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

Conditions

Malaria

Keywords

Malaria; Cognition; Prevention & control; Anemia; Chemoprophylaxis; Mortality; Children; Randomized controlled trial; Education; Long-term effects; The Gambia; Africa, West

Outcome Measures

Primary Outcomes (4)

• Mortality

• Episodes of Fever Associated with Malaria Parasitaemia

• Cognitive Abilities in late adolescence

• Educational Attainment (Years spent at school)

Interventions

Maloprim DRUG

Eligibility Criteria

• Age: 3 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Medical Research Council Field Station

Farafenni, Central River Division, The Gambia

Location

Related Publications (3)

• 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.

  PMID: 2896957 RESULT

• 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.

  PMID: 2096501 RESULT

• 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.

  PMID: 8594677 RESULT

MeSH Terms

Conditions

Malaria; Anemia

Interventions

Maloprim

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Brian M Greenwood, MD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Matthew CH Jukes, DPhil

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 20, 2006
• First Posted: February 22, 2006
• Study Start: April 1, 1982
• Study Completion: September 1, 2001
• Last Updated: October 3, 2023

Record last verified: 2023-10

Locations

TH (1)