Malaria Clinical Trial
Official title:
Impact of Repeated Anthelminthic Treatment on Malaria in School Children: an Individual Randomized, Double-blind, Placebo-controlled Trial in Western Kenya
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.
Status | Completed |
Enrollment | 2377 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 5 Years to 18 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Kenya | KEMRI-Wellcome Trust Programme | Nairobi |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine | European Union, Wellcome Trust |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
Secondary | Prevalence and density of Plasmodium spp. infection. | 18 months | No | |
Secondary | Antibody isotype response to Plasmodium antigens. | ELISA analysis will be carried out to determine IgG1and IgG3 antibody response to Plasmodium antigens (schizont extract and Merozoite Surface Proteins (MSP) | 18 months | No |
Secondary | Antibody isotype response to helminth antigens. | ELISA analysis will be carried out to determine and IgE, IgG2, IgG4 and IgM responses to hookworm and Ascaris lumbricoides. | 18 months | No |
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