Comparing two different doses of praziquantel in Lao school children to treat infections of Schistosoma mekongi and Opisthorchis viverrini

ISRCTN ISRCTN57714676
DOI https://doi.org/10.1186/ISRCTN57714676
Secondary identifying numbers N/A
Submission date
12/04/2011
Registration date
05/05/2011
Last edited
08/10/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Peter Odermatt
Scientific

Socinstrasse 57
Basel
4002
Switzerland

+41 61 284 8214
peter.odermatt@unibas.ch

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEfficacy of praziquantel against Schistosoma mekongi and Opisthorchis viverrini: a randomized, single-blinded dose comparison
Study objectivesA 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(s)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)
Health condition(s) or problem(s) studiedSchistosoma mekongi and Opisthorchis viverrini infections
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Praziquantel
Primary outcome measureSchistosoma 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 measures1. 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 study start date01/02/2007
Completion date31/05/2007

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Years
Upper age limit16 Years
SexBoth
Target number of participants308 (210 at time of registration)
Key inclusion criteria1. School children (males and females) between 6-16 years
Key exclusion criteria1. Pregnancy
2. Severe illness
3. Non-consent
Date of first enrolment01/02/2007
Date of final enrolment31/05/2007

Locations

Countries of recruitment

  • Lao People's Democratic Republic
  • Switzerland

Study participating centre

Socinstrasse 57
Basel
4002
Switzerland

Sponsor information

Swiss Tropical and Public Health Institute (Switzerland)
Government

Socinstrasse 57
Basel
4002
Switzerland

+41 61 284 8111
peter.odermatt@unibas.ch
http://www.swisstph.ch
ROR logo https://ror.org/03adhka07

Funders

Funder type

Government

Swiss National Science Foundation and Swiss Agency for Development and Cooperation

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2012 Yes No
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