Impact of Repeated Anthelminthic Treatment on Malaria in School Children: an Individual Randomized, Double-blind, Placebo-controlled Trial in Western Kenya
This will be an individual randomized, double-blinded controlled trial to evaluate the
impact of intensive versus annual anthelminthic treatment on the incidence of clinical
malaria in healthy school children.
The target population includes children attending primary school in western Kenya. The
accessible population includes children attending the participating primary schools in
standards 1-7 in western Kenya. The unit of analysis is the individual child. Children with
informed consent and assent will be screened for helminth infections and those children
found to be infected with either Ascaris lumbricoides or hookworm species will be recruited
into the study. These children will be randomized to one or two groups, receiving either
albendazole treatment every three months or albendazole at the start of the study and
placebo every three months thereafter. Cross-sectional health surveys will be conducted
before the intervention and at 6, 12 and 18 months follow-up. Weekly active case detection
during school visits will be undertaken.
Interventional
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Incidence of clinical malaria
Incidence of clinical malaria, defined as fever (axillary temperature > 37.5 °C) or a reported history of fever within the preceding 24 hours in conjunction with a slide positive for Plasmodium spp. parasites at any density during 18 months of follow-up.
18 months
No
Simon J Brooker, DPhil
Principal Investigator
London School of Hygiene and Tropical Medicine
Kenya: Ethical Review Committee
2242
NCT01658774
September 2012
December 2014
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