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Effect of repeated three-monthly albendazole treatments on malaria and allergic disease
ISRCTN ISRCTN83830814
DOI 10.1186/ISRCTN83830814
ClinicalTrials.gov identifier
EudraCT number
Public title Effect of repeated three-monthly albendazole treatments on malaria and allergic disease
Scientific title Parasitic infections and Inflammatory Diseases: The web of immune responses, host genetics and environmental exposure
Acronym N/A
Serial number at source 05-PP-35
Study hypothesis Intestinal helminth infections suppress atopy and incidence of malaria and this suppression is reversible by antihelminthic treatment
Lay summary Not provided at time of registration
Ethics approval University of Indonesia, approved on 11/09/2006 (ref: 194/ PT02.FK/Etik/2006)
Study design Randomised double-blind placebo-controlled trial
Countries of recruitment Indonesia
Disease/condition/study domain Helminth and malaria parasitic diseases
Participants - inclusion criteria 1. Both males and females
2. Age >=2 years. No upper age limit.
3. Those who have given informed consent
Participants - exclusion criteria 1. History of chronic liver, heart or central nervous system (CNS) disease
2. Allergy to albendazole
Anticipated start date 01/11/2008
Anticipated end date 01/11/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 4,000
Interventions 400 mg albendazole (oral) or matching placebo every three months for 2 years.
Primary outcome measure(s) 1. Prevalence of malaria parasite, assessed throughout the study for 3 years
2. Infection with intestinal helminth before treatment and within 1, 2 and 3 years after start of treatment
3. Skin reactivity to allergens assessed before treatment and within 1, 2 and 3 years after start of treatment
Secondary outcome measure(s) Immune response to malaria and helminth antigens, assessed before albendazole treatment and within 1, 2 and 3 years after the start of treatment (with the last treatment given at least 2 months before immunological determination).
Sources of funding Royal Netherlands Academy of Arts and Sciences (Netherlands) (ref: 05-PP-35)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23526959
Contact name Prof  Maria  Yazdanbakhsh
  Address Department of Parasitology
Leiden University Medical Centre
Albinusdreef 2
  City/town Leiden
  Zip/Postcode 2333 ZA
  Country Netherlands
  Email M.Yazdanbakhsh@lumc.nl
Sponsor Royal Netherlands Academy of Arts and Sciences (Netherlands)
  Address Kloveniersburgwal 29
  City/town Amsterdam
  Zip/Postcode 1011 JV
  Country Netherlands
  Email knaw@bureau.knaw.nl
  Sponsor website: http://www.knaw.nl
Date applied 08/12/2008
Last edited 23/09/2013
Date ISRCTN assigned 27/02/2009
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