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Impact of Repeated Anthelminthic Treatment on Malaria in School Children: an Individual Randomized, Double-blind, Placebo-controlled Trial in Western Kenya


N/A
5 Years
18 Years
Not Enrolling
Both
Intestinal Helminthiasis, Ascariasis, Hookworm, Malaria

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Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Incidence of clinical malaria

Outcome Description:

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.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Simon J Brooker, DPhil

Investigator Role:

Principal Investigator

Investigator Affiliation:

London School of Hygiene and Tropical Medicine

Authority:

Kenya: Ethical Review Committee

Study ID:

2242

NCT ID:

NCT01658774

Start Date:

September 2012

Completion Date:

December 2014

Related Keywords:

  • Intestinal Helminthiasis
  • Ascariasis
  • Hookworm
  • Malaria
  • Hookworm Infections
  • Ascariasis
  • Ascaridiasis
  • Helminthiasis
  • Malaria
  • Intestinal Diseases

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