Early Childhood Malaria Prevention With Maloprim in The Gambia
Primary Purpose
Malaria
Status
Completed
Phase
Phase 4
Locations
Gambia
Study Type
Interventional
Intervention
Maloprim
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring Malaria, Cognition, Prevention & control, Anemia, Chemoprophylaxis, Mortality, Children, Randomized controlled trial, Education, Long-term effects, The Gambia, Africa, West
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
Sites / Locations
- Medical Research Council Field Station
Outcomes
Primary Outcome Measures
Mortality
Episodes of Fever Associated with Malaria Parasitaemia
Cognitive Abilities in late adolescence
Educational Attainment (Years spent at school)
Secondary Outcome Measures
Full Information
NCT ID
NCT00294580
First Posted
February 20, 2006
Last Updated
October 2, 2023
Sponsor
Imperial College London
Collaborators
Medical Research Council Unit, The Gambia, Government of the Gambia, London School of Hygiene and Tropical Medicine, Partnership for Child Development, Wellcome Trust
1. Study Identification
Unique Protocol Identification Number
NCT00294580
Brief Title
Early Childhood Malaria Prevention With Maloprim in The Gambia
Official Title
Comparison of Two Strategies for Control of Malaria Within A Primary Health Care Programme in the Gambia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 1982 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Imperial College London
Collaborators
Medical Research Council Unit, The Gambia, Government of the Gambia, London School of Hygiene and Tropical Medicine, Partnership for Child Development, Wellcome Trust
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malaria, Cognition, Prevention & control, Anemia, Chemoprophylaxis, Mortality, Children, Randomized controlled trial, Education, Long-term effects, The Gambia, Africa, West
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
2253 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Maloprim
Primary Outcome Measure Information:
Title
Mortality
Title
Episodes of Fever Associated with Malaria Parasitaemia
Title
Cognitive Abilities in late adolescence
Title
Educational Attainment (Years spent at school)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian M Greenwood, MD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew CH Jukes, DPhil
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Research Council Field Station
City
Farafenni
State/Province
Central River Division
Country
Gambia
12. IPD Sharing Statement
Citations:
PubMed Identifier
2896957
Citation
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.
Results Reference
result
PubMed Identifier
2096501
Citation
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.
Results Reference
result
PubMed Identifier
8594677
Citation
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.
Results Reference
result
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Early Childhood Malaria Prevention With Maloprim in The Gambia
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