A research study of the role of artesunate in the treatment of Fasciola hepatica
| ISRCTN | ISRCTN75869075 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75869075 |
| Secondary identifying numbers | 061330 |
- Submission date
- 16/03/2007
- Registration date
- 16/03/2007
- Last edited
- 21/03/2013
- 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 Jeremy Farrar
Scientific
Scientific
Oxford University Clinical Research Unit
Hospital for Tropical Diseases
Ho Chi Minh City
5
Viet Nam
| Phone | +84 8 9237954 |
|---|---|
| jfarrar@oucru.org |
Study information
| Study design | Open label randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | A randomised controlled pilot study of artesunate versus triclabendazole for the treatment of human fascioliasis in central Vietnam |
| Study acronym | CE |
| Study objectives | The primary purpose of this protocol is to evaluate Artesunate as compared to Trichlorbendazole in the treatment of Fasciola hepatica with the hypothesis that Artesunate will improve the treatment of this disease. |
| Ethics approval(s) | Approval received from the Ethical and Scientific Committee of the Hospital for Tropical Diseases, Ho Chi Minh City (Viet Nam) |
| Health condition(s) or problem(s) studied | Fasciola hepatica |
| Intervention | Group A will be treated using triclabendazole at the recommended dose of 20 mg/Kg body weight and given as two doses of 10 mg/Kg body weight after food with a time lapse of 12 hours between doses. Group B will be treated using oral artesunate at a dose of 4 mg/kg body weight/day for ten days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Artesunate, trichlorbendazole |
| Primary outcome measure | Clinical improvement in presenting complaint. |
| Secondary outcome measures | 1. Improvement in ultrasound appearance 2. Changes in eosinophilic count in peripheral blood 3. Biochemical parameters to return to normal 4. Haematology parameters return to normal 5. Absence of eggs in the stool |
| Overall study start date | 01/07/2005 |
| Completion date | 30/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Either gender, aged greater than 8 years 2. Fasciola hepatica 3. Gives consent |
| Key exclusion criteria | Does not meet with inclusion criteria |
| Date of first enrolment | 01/07/2005 |
| Date of final enrolment | 30/03/2007 |
Locations
Countries of recruitment
- Viet Nam
Study participating centre
Oxford University Clinical Research Unit
Ho Chi Minh City
5
Viet Nam
5
Viet Nam
Sponsor information
University of Oxford (UK)
University/education
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
| Phone | +44 (0)1865 270143 |
|---|---|
| research.services@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 061330)
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 | 01/03/2008 | Yes | No |
