Impact of Repeated Anthelmintic Treatment on the Risk of Malaria in Kenyan School Children
Condition: Intestinal Helminthiasis; Ascariasis; Hookworm; Malaria
MeSH terms: Malaria; Helminthiasis; Ascariasis
Study type: Interventional

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.
    

Detailed description: 
      This will be an individual randomized, single-blind 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.
    

Intervention name(s): Albendazole; Vitamin C
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Single 400mg dose; 500 mg Vitamin C
Other intervention name(s): Zentel
Intervention MeSH terms: Albendazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment