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Safety and efficacy of single-dose and triple-dose albendazole and mebendazole against soil-transmitted helminth infections in humans
ISRCTN ISRCTN47375023
DOI 10.1186/ISRCTN47375023
ClinicalTrials.gov identifier
EudraCT number
Public title Safety and efficacy of single-dose and triple-dose albendazole and mebendazole against soil-transmitted helminth infections in humans
Scientific title Safety and efficacy of single-dose and triple-dose albendazole and mebendazole against soil-transmitted helminth infections in humans: open-label randomised-controlled trial in China
Acronym N/A
Serial number at source N/A
Study hypothesis 1. Both albendazole and mebendazole are safe for treating common soil-transmitted helminth infections in humans
2. Single-dose oral albendazole and single-dose oral mebendazole are both highly active against Ascaris lumbricoides, and result in high faecal egg count reduction rates for hookworm and Trichuris trichiura
3. Single-dose oral albendazole is more efficacious than single-dose oral mebendazole against hookworm infections
4. Triple-dose oral albendazole and triple-dose oral mebendazole are significantly more efficacious against T. trichiura than single-dose oral regimens
Lay summary Not provided at time of registration
Ethics approval 1. Ethics Committee of Basel (Ethikkommission beider Basel [EKBB]), approved on the 23rd September 2008 (ref: 294/08)
2. Academic Board of the National Institute of Parasitic Diseases (IPD), Chinese Centre for Disease Control and Prevention (China CDC), approved on the 17th September 2008 (ref: 2008091701)
Study design Community-based, phase IV, open-label/single-blind, randomised controlled trial
Countries of recruitment China
Disease/condition/study domain Soil-transmitted helminth infections (Ascaris lumbricoides, Trichuris trichiura, hookworms)
Participants - inclusion criteria 1. Age: greater than or equal to 5 years old
2. Sex: males and females
3. Residency: resident of Nongyang village in Menghai county, Yunnan province, People’s Republic of China
4. Registration, participation: signing of written informed consent sheet (5 - 17 year olds: additional written approval by parents or legal guardians), willingness to comply with study procedures (stool submission, drug treatment, alcohol abstinence at day of treatment)
5. Absence of systemic or chronic diagnosed or perceivable illness as assessed by medical personnel upon enrolment and again at each day of treatment
6. Females: not pregnant (as verbally assessed by female medical personnel upon enrolment and again at each day of treatment)
Participants - exclusion criteria 1. Age: less than 5 years
2. Residency: not a permanent resident of Nongyang village in Menghai county, Yunnan province, People’s Republic of China
3. Registration, participation: no written informed consent sheet signed or parental approval not obtained, unwillingness to comply with all study procedures
4. Presence or suspicion of any abnormal medical condition which is known or suspected to interfere with anthelminthic treatment
5. Known hypersensitivity to any anthelminthic drugs
6. Recent history of anthelminthic treatment
7. Current or past (within 1 month) participation in any other medical trial
8. For females: suspected or verified pregnancy
Anticipated start date 01/11/2008
Anticipated end date 31/01/2009
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 370 (max. 400)
Interventions Stool collection will be carried out for baseline parasitological assessment (two stools/participant, each stool tested for the presence of helminth eggs by the Kato-Katz [2 slides/stool] and FLOTAC method).

The participants will be randomly allocated to the following four trial arms:
1. Albendazole (oral) single dose: 400 mg
2. Mebendazole (oral) single dose: 500 mg
3. Triple-dose albendazole (oral): 400 mg daily for 3 days
4. Triple-dose mebendazole (oral): 500 mg daily for 3 days

The participants are blinded regarding which drug they receive but not regarding which treatment schedule they belong to (1 or 3 day treatment) since no placebos are used. The investigators are aware of drug type and schedule at each stage of the trial.

Adverse drug-related events will be monitored for 24 hours post-application. Stool collection will be repeated for parasitological treatment efficacy assessment (two stools/participant, each stool tested for the presence of helminth eggs by the Kato-Katz [2 slides/stool] and FLOTAC method).

Details of Joint Sponsor:
National Institute of Parasitic Diseases
Chinese Centre for Disease Control and Prevention
207 Rui Jin Er Road
Shanghai 200025
China
Tel: +86 (0)136 7161 6056
Primary outcome measure(s) Cure rates of single-dose and triple-dose oral albendazole and mebendazole for treating common soil-transmitted helminth (STH) infections, especially hookworms, assessed at 2 - 3 weeks post-treatment.
Secondary outcome measure(s) 1. Safety of single-dose and triple-dose oral albendazole and mebendazole against common STH infections
2. Egg-reduction rates of single-dose and triple-dose oral albendazole and mebendazole against common STH infections

Assessed at 2 - 3 weeks post-treatment.
Sources of funding 1. Stanley Thomas Johnson Foundation (Switzerland)
2. Swiss National Science Foundation (SNSF) (Switzerland) (ref: PBBSP3-123193)
Trial website
Publications 1.2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21980373
Contact name Dr  Peter  Steinmann
  Address Swiss Tropical Institute
Socinstrasse 57
  City/town Basel
  Zip/Postcode CH-4051
  Country Switzerland
  Tel +41 (0)61 284 8129
  Fax +41 (0)61 284 8105
  Email peter.steinmann@unibas.ch
Sponsor Swiss Tropical Institute (STI) (Switzerland)
  Address Socinstrasse 57
  City/town Basel
  Zip/Postcode CH-4051
  Country Switzerland
  Tel +41 (0)61 284 8111
  Email peter.steinmann@unibas.ch
  Sponsor website: http://www.sti.ch
Date applied 10/11/2008
Last edited 10/04/2012
Date ISRCTN assigned 28/11/2008
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