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Impact of Repeated Anthelmintic Treatment on the Risk of Malaria in Kenyan School Children

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
European Union
Wellcome Trust
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01658774
First received: July 19, 2012
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Intestinal Helminthiasis
Ascariasis
Hookworm
Malaria
Drug: Albendazole
Dietary Supplement: Vitamin C

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Repeated Anthelminthic Treatment on Malaria in School Children: an Individual Randomized, Double-blind, Placebo-controlled Trial in Western Kenya

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Incidence of clinical malaria [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Prevalence and density of Plasmodium spp. infection. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Antibody isotype response to Plasmodium antigens. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    ELISA analysis will be carried out to determine IgG1and IgG3 antibody response to Plasmodium antigens (schizont extract and Merozoite Surface Proteins (MSP)

  • Antibody isotype response to helminth antigens. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    ELISA analysis will be carried out to determine and IgE, IgG2, IgG4 and IgM responses to hookworm and Ascaris lumbricoides.


Enrollment: 2377
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Albendazole & Vitamin C
Anthelmintics. A single dose of Albendazole (400mg) at month 0 and single dose of Vitamin C (500 mg) at 3, 6, 9 and 12 months.
Drug: Albendazole
Single 400mg dose
Other Name: Zentel
Dietary Supplement: Vitamin C
500 mg Vitamin C
Experimental: Albendazole
Anthelmintics. A single does of Albendazole (400mg) every three months for 12 months
Drug: Albendazole
Single 400mg dose
Other Name: Zentel

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.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658774

Locations
Kenya
KEMRI-Wellcome Trust Programme
Nairobi, Kenya, P.O. Box 43640 - 00100
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
European Union
Wellcome Trust
Investigators
Principal Investigator: Simon J Brooker, DPhil London School of Hygiene and Tropical Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01658774     History of Changes
Other Study ID Numbers: 2242, 241642
Study First Received: July 19, 2012
Last Updated: February 14, 2014
Health Authority: Kenya: Ethical Review Committee

Additional relevant MeSH terms:
Ascariasis
Helminthiasis
Intestinal Diseases
Malaria
Ascaridida Infections
Digestive System Diseases
Gastrointestinal Diseases
Nematode Infections
Parasitic Diseases
Protozoan Infections
Secernentea Infections
Albendazole
Anthelmintics
Ascorbic Acid
Vitamins
Anti-Infective Agents
Anticestodal Agents
Antimitotic Agents
Antineoplastic Agents
Antioxidants
Antiparasitic Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Growth Substances
Micronutrients
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 25, 2014