Mefloquine, artesunate, mefloquine-artesunate and tribendimidine against opisthorchiasis
| ISRCTN | ISRCTN23425032 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23425032 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/02/2010
- Registration date
- 16/03/2010
- Last edited
- 16/03/2011
- 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
Prof Jennifer Keiser
Scientific
Scientific
Department of Medical Parasitology and Infection Biology
Swiss Tropical and Public Health Institute
Socinstr. 57
Basel
4051
Switzerland
Study information
| Study design | Phase 2 randomised exploratory open label active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Mefloquine, artesunate, mefloquine-artesunate and tribendimidine in the treatment of Opisthorchis viverrini infection in Laos |
| Study acronym | MQAS-Opi |
| Study objectives | Mefloquine and artesunate, administered singly or in combination, and tribendimidine show efficacy against Opisthorchis viverrini in school-aged children in Africa |
| Ethics approval(s) | 1. Ethics commission of Basel (Ethikkomission beider Basel [EKBB]), Switzerland approved on the 23rd July 2009 (ref: 209/09) 2. Ministry of Health Lao PDR approved on the 3rd February 2010 (ref: 25/2010) |
| Health condition(s) or problem(s) studied | Infection with Opisthorchis viverrini |
| Intervention | Drug administration, namely 1. Mefloquine (1x 25 mg/kg) 2. Artesunate (10 mg/kg in three divided doses within 1 day) 3. Mefloquine-artesunate combination (300/750 mg in three divided doses within 3 days) 4. Praziquantel (3x 25 mg/kg within 1 day) 5. Tribendimidine (1 x 200 mg (below age of 14) or 400 mg (above age of 14) The duration of treatment is 1-3 days, depending on the drug. Duration of follow up is 3-5 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Artesunate, mefloquine, praziquantel, tribendimidine |
| Primary outcome measure | Cure rate and egg reduction rate 21-28 Days post treatment by multiple stool sampling (Kato Katz method, Ether concentration technique and PCR) |
| Secondary outcome measures | Adverse events Patients will be monitored for 3 hours post treatment and once daily for 5 days. Details of adverse events will be recorded by the study physician during the trial including variables describing their incidence, onset, cessation, duration, intensity, frequency, seriousness, and causality. |
| Overall study start date | 01/03/2010 |
| Completion date | 01/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Patients (male and female schoolchildren older than 8 years) infected with O. viverrini, as assessed by the presence of eggs in the stool 2. Weight of patient greater than 25 kg 3. Able and willing to be examined by a study physician at the beginning of the study and at the end-of study (3 weeks post-treatment) 4. Able and willing to provide multiple stool samples at the beginning and end of study 5. Absence of major systemic illnesses, as assessed by the medical doctor, upon initial clinical assessment 6. Absence of psychiatric and neurological disorders 7. No known or reported hypersensitivity to mefloquine, tribendimidine and/or artesunate 8. No known or reported history of chronic illness as cancer, diabetes, chronic heart, liver or renal disease 9. Signed written informed consent sheet 10. For females aged 12 years and above, not pregnant in the first trimester, as assessed by a pregnancy test, upon initial clinical assessment |
| Key exclusion criteria | 1. Pregnancy first trimester 2. Presence of any abnormal medical condition, judged by the study physician 3. History of acute or severe chronic disease 4. Known or reported psychiatric or neurological disorders 5. Use of artesunate, artemether, any ACT, mefloquine or praziquantel within the past month 6. Attending other clinical trials during the study |
| Date of first enrolment | 01/03/2010 |
| Date of final enrolment | 01/05/2010 |
Locations
Countries of recruitment
- Lao People's Democratic Republic
- Switzerland
Study participating centre
Department of Medical Parasitology and Infection Biology
Basel
4051
Switzerland
4051
Switzerland
Sponsor information
Swiss Tropical and Public Health Insitute (Switzerland)
Research organisation
Research organisation
Socinstr. 57
4051 Basel
Basel
4051
Switzerland
"ROR" |
https://ror.org/03adhka07 |
|---|
Funders
Funder type
University/education
University of Basel (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/02/2011 | Yes | No |
