A research study of the role of artesunate in the treatment of Fasciola hepatica

ISRCTN	ISRCTN75869075
DOI	https://doi.org/10.1186/ISRCTN75869075
Protocol serial number	061330
Sponsor	University of Oxford (UK)
Funder	The Wellcome Trust (UK) (grant ref: 061330)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jeremy Farrar
Scientific

Oxford University Clinical Research Unit
Hospital for Tropical Diseases
Ho Chi Minh City
5
Viet Nam

Phone	+84 8 9237954
Email	jfarrar@oucru.org

Primary study design	Interventional
Study design	Open label randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Artesunate, trichlorbendazole
Primary outcome measure(s)	Clinical improvement in presenting complaint.
Key secondary outcome measure(s)	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
Completion date	30/03/2007

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	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

Oxford University Clinical Research Unit

Ho Chi Minh City
5
Viet Nam

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2008		Yes	No