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ISRCTN
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ISRCTN57714676
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DOI
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10.1186/ISRCTN57714676
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Comparing two different doses of praziquantel in Lao school children to treat infections of Schistosoma mekongi and Opisthorchis viverrini
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Scientific title
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Efficacy of praziquantel against Schistosoma mekongi and Opisthorchis viverrini: a randomized, single-blinded dose comparison
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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
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Lay summary
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Not provided at time of registration
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Ethics approval
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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)
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Study design
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Randomized controlled trial
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Countries of recruitment
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Laos
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Disease/condition/study domain
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Schistosoma mekongi and Opisthorchis viverrini infections
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Participants - inclusion criteria
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1. School children (males and females) between 6-16 years
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Participants - exclusion criteria
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1. Pregnancy
2. Severe illness
3. Non-consent
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Anticipated start date
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01/02/2007
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Anticipated end date
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31/05/2007
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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308 (210 at time of registration)
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Interventions
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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)
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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)
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Sources of funding
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Swiss National Science Foundation and Swiss Agency for Development and Cooperation
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Trial website
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Publications
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1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22848766
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Contact name
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Dr
Peter
Odermatt
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Address
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Socinstrasse 57
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City/town
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Basel
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Zip/Postcode
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4002
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Country
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Switzerland
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Tel
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+41 61 284 8214
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Fax
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+41 61 284 8105
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Email
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peter.odermatt@unibas.ch
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Sponsor
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Swiss Tropical and Public Health Institute (Switzerland)
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Address
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Socinstrasse 57
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City/town
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Basel
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Zip/Postcode
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4002
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Country
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Switzerland
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Tel
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+41 61 284 8111
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Email
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peter.odermatt@unibas.ch
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Sponsor website:
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http://www.swisstph.ch
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Date applied
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12/04/2011
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Last edited
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08/10/2012
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Date ISRCTN assigned
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05/05/2011
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