Condition category
Infections and Infestations
Date applied
16/03/2007
Date assigned
16/03/2007
Last edited
21/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ox.ac.uk/

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

  1. 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.

Additional files

Editorial Notes