Impact of Repeated Anthelmintic Treatment on the Risk of Malaria in Kenyan School Children
Impact of Repeated Anthelminthic Treatment on Malaria in School Children: an Individual Randomized, Double-blind, Placebo-controlled Trial in Western Kenya
2 other identifiers
interventional
2,377
1 country
1
Brief Summary
Many school children in Kenya are infected with plasmodia and helminth species and are at risk of coinfection. It has been suggested that the immune response evoked by helminth infections may modify immune responses to plasmodia species and consequently alter infection and disease risks. However, studies conducted to date have been typically cross-sectional and produced conflicting results, and there is a need for longitudinal studies to better understand the clinical consequences for individuals harbouring coinfection. This study aims to investigate the impact of intensive (once every 3 months) anthelminthic treatment versus annual treatment on the risk of clinical malaria and on immune responses among school children aged 5-14 years in Western Province. Specifically, this study aims to investigate the impact of intensive anthelminthic treatment on (i) the incidence of clinical malaria in school children, assessed using active case detection; (ii) the prevalence and density of Plasmodium spp. infection, using repeat cross-sectional surveys; and (iii) malaria and helminth specific immune responses. The study hypothesis is that intensive anthelminthic treatment among children infected with either Ascaris lumbricoides or hookworm modifies human host immune responses to plasmodia and helminth infections, and therefore alters the risk of Plasmodium infection and clinical disease. This individually randomised trial will recruit 1,450 children aged 5-14 years found to be infected with either Ascaris lumbricoides or hookworm species. Recruited children will be randomized to receive albendazole treatment either every three months or annually and monitored through periodic surveillance for clinical malaria episodes over 18 months. In addition, blood samples will be collected from sub-sample of children and screened for malaria specific immunoglobulin (Ig)G1 and IgG3 and helminth specific IgE, IgG2, IgG4 and IgM. Cell culture supernatants will be assayed for interferon (IFN)-γ, tumor necrosis factor (TNF)-α, interleukin (IL)-10, IL-5, IL-4 and IL-2.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2012
CompletedFirst Posted
Study publicly available on registry
August 7, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedApril 10, 2015
February 1, 2014
2 years
July 19, 2012
April 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Prevalence and density of Plasmodium spp. infection.
18 months
Antibody isotype response to Plasmodium antigens.
18 months
Antibody isotype response to helminth antigens.
18 months
Study Arms (2)
Albendazole & Vitamin C
ACTIVE COMPARATORAnthelmintics. A single dose of Albendazole (400mg) at month 0 and single dose of Vitamin C (500 mg) at 3, 6, 9 and 12 months.
Albendazole
EXPERIMENTALAnthelmintics. A single does of Albendazole (400mg) every three months for 12 months
Interventions
Eligibility Criteria
You may qualify if:
- Pupils enrolled at participating schools in classes 1-7.
- Provision of informed consent from parent or legal guardian.
- Provision of assent by student.
- Detectable infection with A.lumbricoides, T. trichiura and/or hookworm species.
You may not qualify if:
- Pupils unwilling to participate in the study.
- Pupils who are infected with S. haematobium or S. mansoni. These children will be treated with praziquantel.
- Known or suspected sickle-cell trait.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- London School of Hygiene and Tropical Medicinelead
- European Unioncollaborator
- Wellcome Trustcollaborator
Study Sites (1)
KEMRI-Wellcome Trust Programme
Nairobi, P.O. Box 43640 - 00100, Kenya
Related Publications (1)
Kepha S, Nuwaha F, Nikolay B, Gichuki P, Mwandawiro CS, Mwinzi PN, Odiere MR, Edwards T, Allen E, Brooker SJ. Effect of Repeated Anthelminthic Treatment on Malaria in School Children in Kenya: A Randomized, Open-Label, Equivalence Trial. J Infect Dis. 2016 Jan 15;213(2):266-75. doi: 10.1093/infdis/jiv382. Epub 2015 Jul 13.
PMID: 26170395DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon J Brooker, DPhil
London School of Hygiene and Tropical Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2012
First Posted
August 7, 2012
Study Start
January 1, 2013
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
April 10, 2015
Record last verified: 2014-02