Contact information
Type
Scientific
Primary contact
Dr Jeremy Farrar
ORCID ID
Contact details
Oxford University Clinical Research Unit
Hospital for Tropical Diseases
Ho Chi Minh City
5
Viet Nam
+84 8 9237954
jfarrar@oucru.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
061330
Study information
Scientific title
A randomised controlled pilot study of artesunate versus triclabendazole for the treatment of human fascioliasis in central Vietnam
Acronym
CE
Study hypothesis
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
Approval received from the Ethical and Scientific Committee of the Hospital for Tropical Diseases, Ho Chi Minh City (Viet Nam)
Study design
Open label randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Artesunate, trichlorbendazole
Primary outcome measures
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 trial start date
01/07/2005
Overall trial end date
30/03/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Either gender, aged greater than 8 years
2. Fasciola hepatica
3. Gives consent
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
100
Participant exclusion criteria
Does not meet with inclusion criteria
Recruitment start date
01/07/2005
Recruitment end date
30/03/2007
Locations
Countries of recruitment
Viet Nam
Trial participating centre
Oxford University Clinical Research Unit
Ho Chi Minh City
5
Viet Nam
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 270143
research.services@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 061330)
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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18337331
Publication citations
-
Results
Hien TT, Truong NT, Minh NH, Dat HD, Dung NT, Hue NT, Dung TK, Tuan PQ, Campbell JI, Farrar JJ, Day JN, A randomized controlled pilot study of artesunate versus triclabendazole for human fascioliasis in central Vietnam., Am. J. Trop. Med. Hyg., 2008, 78, 3, 388-392.