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 |
| Protocol serial number | N/A |
| Sponsor | Swiss Tropical and Public Health Institute (Switzerland) |
| Funder | Swiss National Science Foundation and Swiss Agency for Development and Cooperation |
- 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
Scientific
Socinstrasse 57
Basel
4002
Switzerland
| Phone | +41 61 284 8214 |
|---|---|
| peter.odermatt@unibas.ch |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Efficacy of praziquantel against Schistosoma mekongi and Opisthorchis viverrini: a randomized, single-blinded dose comparison |
| Study objectives | 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(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) studied | 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 / device / biological / vaccine name(s) | Praziquantel |
| 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. |
| Key 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 |
| Completion date | 31/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 308 |
| Key inclusion criteria | 1. School children (males and females) between 6-16 years |
| Key exclusion criteria | 1. Pregnancy 2. Severe illness 3. Non-consent |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 31/05/2007 |
Locations
Countries of recruitment
- Lao People's Democratic Republic
- Switzerland
Study participating centre
Socinstrasse 57
Basel
4002
Switzerland
4002
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
