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Comparing two different doses of praziquantel in Lao school children to treat infections of Schistosoma mekongi and Opisthorchis viverrini
ISRCTN ISRCTN57714676
DOI 10.1186/ISRCTN57714676
ClinicalTrials.gov identifier
EudraCT number
Public title Comparing two different doses of praziquantel in Lao school children to treat infections of Schistosoma mekongi and Opisthorchis viverrini
Scientific title Efficacy of praziquantel against Schistosoma mekongi and Opisthorchis viverrini: a randomized, single-blinded dose comparison
Acronym N/A
Serial number at source N/A
Study hypothesis A 75 mg dose (per kilogram of body weight) of praziquantel is more efficacious in clearing a Schistosoma mekongi and Opisthorchis viverrini infections than a 40 mg dose (per kilogram of body weight) of praziquantel
Lay summary Not provided at time of registration
Ethics approval National Ethics Committee, Laos (Ref:103/NECHR, 29/01/2007)
Ethics commission of the State of Basel, Switzerland (Ethikkommission beider Basel, EKBB) (Ref: 255/06, amendment of 14/02/2007)
Study design Randomized controlled trial
Countries of recruitment Laos
Disease/condition/study domain Schistosoma mekongi and Opisthorchis viverrini infections
Participants - inclusion criteria 1. School children (males and females) between 6-16 years
Participants - exclusion criteria 1. Pregnancy
2. Severe illness
3. Non-consent
Anticipated start date 01/02/2007
Anticipated end date 31/05/2007
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 308 (210 at time of registration)
Interventions 1. Praziquantel 40 mg / kg body weight (1 dose) versus
2. Praziquantel 75 mg / kg body weight (divided into 2 doses of 50 mg/kg + 25 mg/kg, 4 hours apart)
Primary outcome measure(s) Schistosoma mekongi and Opisthorchis viverrini infection clearance (no eggs in 3 stool samples examined with Kato-Katz technique) at 28 and 90 days after treatment.
Secondary outcome measure(s) 1. Reduction of intensity of infection (reduction of mean number of S. mekongi and O.viverrini eggs per gram of stool sample assessed by Kato-Katz technique) at 28 and 90 days after treatment
2. Diagnostic sensitivity of increasing number of Kato-Katz thick smears before and 28 days after treatment. 'Gold' standard: 9 Kato-Katz thick smears (applied on a sub-sample of the population)
Sources of funding Swiss National Science Foundation and Swiss Agency for Development and Cooperation
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22848766
Contact name Dr  Peter  Odermatt
  Address Socinstrasse 57
  City/town Basel
  Zip/Postcode 4002
  Country Switzerland
  Tel +41 61 284 8214
  Fax +41 61 284 8105
  Email peter.odermatt@unibas.ch
Sponsor Swiss Tropical and Public Health Institute (Switzerland)
  Address Socinstrasse 57
  City/town Basel
  Zip/Postcode 4002
  Country Switzerland
  Tel +41 61 284 8111
  Email peter.odermatt@unibas.ch
  Sponsor website: http://www.swisstph.ch
Date applied 12/04/2011
Last edited 08/10/2012
Date ISRCTN assigned 05/05/2011
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