Clinical trial NCT00294580: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Keywords: Malaria
Cognition
Prevention & control
Anemia
Chemoprophylaxis
Mortality
Children
Randomized controlled trial
Education
Long-term effects
The Gambia
Africa, West
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Medical Research Council Unit, The Gambia
name: Government of the Gambia
name: London School of Hygiene and Tropical Medicine
name: Partnership for Child Development
name: Wellcome Trust
First posted: 2006-02-22
Enrollment: 2253
Sex: ALL
Minimum age (years): 3
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Mortality
measure: Episodes of Fever Associated with Malaria Parasitaemia
measure: Cognitive Abilities in late adolescence
measure: Educational Attainment (Years spent at school)
Secondary outcomes:
Other outcomes:
Locations:
city: Farafenni
country: Gambia
facility: Medical Research Council Field Station
state: Central River Division
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Brian M Greenwood, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Matthew CH Jukes, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.