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

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

+84 8 9237954
jfarrar@oucru.org

Study information

Study designOpen label randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleA randomised controlled pilot study of artesunate versus triclabendazole for the treatment of human fascioliasis in central Vietnam
Study acronymCE
Study objectivesThe 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) studiedFasciola hepatica
InterventionGroup 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Artesunate, trichlorbendazole
Primary outcome measureClinical improvement in presenting complaint.
Secondary outcome measures1. 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 date01/07/2005
Completion date30/03/2007

Eligibility

Participant type(s)Patient
Age groupOther
SexAll
Target number of participants100
Key inclusion criteria1. Either gender, aged greater than 8 years
2. Fasciola hepatica
3. Gives consent
Key exclusion criteriaDoes not meet with inclusion criteria
Date of first enrolment01/07/2005
Date of final enrolment30/03/2007

Locations

Countries of recruitment

  • Viet Nam

Study participating centre

Oxford University Clinical Research Unit
Ho Chi Minh City
5
Viet Nam

Sponsor information

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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
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