Condition category
Infections and Infestations
Date applied
12/04/2011
Date assigned
05/05/2011
Last edited
08/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.swisstph.ch

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

  1. 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.

Additional files

Editorial Notes