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Epidemiology and treatment of soil-transmitted helminthiasis, with particular consideration to strongyloidiasis, in Yunnan province, China
ISRCTN ISRCTN01779485
DOI 10.1186/ISRCTN01779485
ClinicalTrials.gov identifier
EudraCT number
Public title Epidemiology and treatment of soil-transmitted helminthiasis, with particular consideration to strongyloidiasis, in Yunnan province, China
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis 1. Single-dose albendazole and single-dose tribendimidine (both drugs will be administered orally at 200 mg for children aged 5-14 years, and 400 mg for individuals aged >=15 years) are safe and efficacious against soil-transmitted helminth infections (Ascaris lumbricoides, hookworm and Trichuris trichuria)
2. Single-dose tribendimidine has an effect on Strongyloides stercoralis and Taenia spp
Lay summary
Ethics approval Ethics Committee of the University and the State of Basel (Ethikkommission beider Basel) (EKBB) Date of approval: 12/06/2007 (ref: 149/07)
Study design Open-label, randomised controlled trial
Countries of recruitment China
Disease/condition/study domain Helminth infections
Participants - inclusion criteria 1. Both males and females, age >=5 years
2. Submission of >=1 stool sample for the baseline parasitological survey
3. For females, not pregnant, as verbally assessed by medical personnel on the day of treatment
4. Absence of major systemic illnesses, as assessed by medical personnel on the day of treatment
5. Written informed consent by the head of the household on behalf of the whole family
Participants - exclusion criteria 1. Presence of any abnormal medical condition, as judged by the medical personnel
2. No stool sample submitted for baseline parasitological survey
3. Enrolled in any other clinical investigation during the study
4. For females: pregnancy
Anticipated start date 01/05/2007
Anticipated end date 31/07/2007
Status of trial Completed
Patient information material
Target number of participants Approximately 300
Interventions The participants who were diagnosed with helminthiases at the baseline parasitological survey were randomly allocated to the following arms:

Arm 1: Single-dose albendazole (oral), 200 mg for children aged 5-14 years, and 400 mg for individuals aged >=15 years
Arm 2: Single-dose tribendimidine (oral), 200 mg for children aged 5-14 years, and 400 mg for individuals aged >=15 years
Primary outcome measure(s) 1. Reduction of infection prevalence of intestinal helminths, assessed by examination of stool samples 2-4 weeks after drug administration
2. Frequency and severity of adverse events were recorded within 24 hours after drug administration
Secondary outcome measure(s) Kato-Katz-derived egg count reduction of common soil-transmitted helminths, assessed 2-4 weeks after drug administration.
Sources of funding Main funder:
1. Commission for Research Partnership with Developing Countries (KFPE) through the Swiss Agency for Development and Cooperation (SDC) (Switzerland)

Other funders:
2. Voluntary Academic Society (Freiwillige Akademische Gesellschaft) (Switzerland)
3. Janggen-Pöhn Foundation (Janggen-Pöhn-Stiftung) (Switzerland)
4. Chinese Ministry of Science and Technology, through their support to the Key Laboratory of Parasite and Vector Biology of the Chinese Ministry of Health (China) (grant ref: 2005DKA21104)
5. Swiss National Science Foundation (Switzerland) (project numbers PPOOB-102883 and PPOOB-119129)
Trial website
Publications Results in: http://www.ncbi.nlm.nih.gov/pubmed/18923706
Contact name Dr  Juerg  Utzinger
  Address Department of Public Health and Epidemiology
Swiss Tropical Institute
Socinstrasse 57
PO Box
  City/town Basel
  Zip/Postcode 4002
  Country Switzerland
  Tel +41 61 284 8129
  Fax +41 61 284 8105
  Email juerg.utzinger@unibas.ch
Sponsor Swiss National Science Foundation (SNSF) (Switzerland)
  Address Wildhainweg 3
PO Box 8232
  City/town Bern
  Zip/Postcode 3001
  Country Switzerland
  Tel +41 31 308 22 22
  Email info@snf.ch
  Sponsor website: http://www.snf.ch
Date applied 16/08/2008
Last edited 13/11/2008
Date ISRCTN assigned 21/08/2008
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