Contact information
Type
Scientific
Primary contact
Dr Peter Odermatt
ORCID ID
Contact details
Socinstrasse 57
Basel
4002
Switzerland
+41 61 284 8214
peter.odermatt@unibas.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Efficacy of praziquantel against Schistosoma mekongi and Opisthorchis viverrini: a randomized, single-blinded dose comparison
Acronym
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Schistosoma mekongi and Opisthorchis viverrini infections
Intervention
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)
Intervention type
Drug
Phase
Not Applicable
Drug names
Praziquantel
Primary outcome measures
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 measures
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)
Overall trial start date
01/02/2007
Overall trial end date
31/05/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. School children (males and females) between 6-16 years
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
308 (210 at time of registration)
Participant exclusion criteria
1. Pregnancy
2. Severe illness
3. Non-consent
Recruitment start date
01/02/2007
Recruitment end date
31/05/2007
Locations
Countries of recruitment
Laos
Trial participating centre
Socinstrasse 57
Basel
4002
Switzerland
Sponsor information
Organisation
Swiss Tropical and Public Health Institute (Switzerland)
Sponsor details
Socinstrasse 57
Basel
4002
Switzerland
+41 61 284 8111
peter.odermatt@unibas.ch
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Swiss National Science Foundation and Swiss Agency for Development and Cooperation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22848766
Publication citations
-
Results
Lovis L, Mak TK, Phongluxa K, Ayé Soukhathammavong P, Vonghachack Y, Keiser J, Vounatsou P, Tanner M, Hatz C, Utzinger J, Odermatt P, Akkhavong K, Efficacy of praziquantel against Schistosoma mekongi and Opisthorchis viverrini: a randomized, single-blinded dose-comparison trial., PLoS Negl Trop Dis, 2012, 6, 7, e1726, doi: 10.1371/journal.pntd.0001726.