Condition category
Infections and Infestations
Date applied
07/03/2012
Date assigned
20/03/2012
Last edited
27/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Clonorchiasis, a disease caused by the oriental liver fluke Clonorchis sinensis, is of considerable public health importance. The disease is constantly present in the People’s Republic of China, Taiwan, Vietnam, and the Republic of Korea, where an estimated 601 million people are at risk and more than 35 million people are infected. There is currently no vaccine available for prevention of clonorchiasis and chemotherapy is the main treatment. However, chemotherapy of clonorchiasis relies on a single drug called praziquantel. Efforts are underway to administer praziquantel more widely, in preventive chemotherapy campaigns. There is some concern that this strategy might result in the development and spread of drug-resistant parasites. There is a need for discovery and development of new drugs. The aim of this study is to assess how well oral tribendimidine works in patients infected with C. sinensis.

Who can participate?
75 individuals with a parasitological-confirmed infection with C. sinensis

What does the study involve?
Patients will be randomly allocated to one of three groups:
- single oral dose of 400 mg tribendimidine
- oral doses of 400 mg tribendimidine daily for 3 days
- praziquantel (25 mg/kg 3 times a day) for 2 consecutive days

What are the possible benefits and risks of participating?
The two drugs which are compared are well known, widely used and have little adverse events. All children enrolled in the study will benefit from a treatment against liver fluke infection and soil transmitted helminths. All diagnosed parasitic infections will be treated according to national guidelines.

Where is the study run from?
Guangdong province, China.

When is study starting and how long is it expected to run for?
The study will last for 5-6 weeks and will take place in March/April 2012.

Who is funding the study?
The study will be funded by DFID/Wellcome Trust/MRC.

Who is the main contact?
Professor Jennifer Keiser

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jennifer Keiser

ORCID ID

Contact details

Socinstr. 57
Basel
4051
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Tribendimidine in the treatment of Clonorchis sinensis infection in the People’s Republic of China

Acronym

Study hypothesis

Tribendimidine achieves a higher efficacy than praziquantel in the treatment of Clonorchis infections

Follow up to http://www.controlled-trials.com/ISRCTN23425032

Ethics approval

Ethikkomission Beider, Basel, 09 February 2012 ref: 375/11

Study design

Randomized exploratory open-label phase II trial with three treatment arms

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Liver fluke infections (Clonorchis sinesis)

Intervention

Group 1: single oral dose of 400 mg tribendimidine
Group 2: oral doses of 400 mg tribendimidine daily for 3 days
Group 3: praziquantel (25 mg/kg 3 times a day) for 2 consecutive days

Follow up is 21 days after treatment. Praziquantel brand names are Biltricide® and Cesol®.

Intervention type

Drug

Phase

Phase II

Drug names

Praziquantel, tribendimidine

Primary outcome measures

Cure rates and egg reduction rates three weeks after treatment:
For diagnosis three stool samples will be collected before and after treatment. From each stool sample three Kato-Katz thick smears will be examined. Additionally 1g of stool will be preserved for later diagnosis with the ether concentration method.

Secondary outcome measures

Adverse events due to specific treatment:
Participants will be monitored 3 hours after treatment. 24 hours after each day of treatment they will be asked with a standard questionnaire for adverse events.

Overall trial start date

10/03/2012

Overall trial end date

10/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients (adults aged ≥18 years) infected with C. sinensis, as assessed by the presence of eggs in the stool
2. Signed written informed consent
3. Able and willing to be examined by a study physician at the beginning of the study and at the end-of study follow-up survey (3 - 4 weeks post-treatment)
4. Able and willing to provide multiple stool samples at the beginning and end of study
5. Absence of major systemic illnesses, psychiatric and neurological disorders as assessed by the medical doctor, upon initial clinical assessment
6. No known or reported hypersensitivity to tribendimidine or praziquantel
7. No known or reported history of chronical illness as cancer, diabetes, chronic heart, liver or renal disease
8. For females, not pregnant in the first trimester, as assessed by a female nurse (interview and pregnancy test if need be), upon initial clinical assessment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

75

Participant exclusion criteria

1. For females, pregnancy in first trimester
2. Presence of any abnormal medical condition, judged by the study physician
3. History of acute or severe chronic disease
4. Known or reported hypersensitivity to tribendimidine or praziquantel
5. Known or reported psychiatric or neurological disorders
6. Use of any anthelmintic within the past month
7. Attending other clinical trials during the study
8. Absence of signed written informed consent sheet

Recruitment start date

10/03/2012

Recruitment end date

10/05/2012

Locations

Countries of recruitment

China

Trial participating centre

Socinstr. 57
Basel
4051
Switzerland

Sponsor information

Organisation

Medical Research Council (UK)

Sponsor details

One Kemble Street
London
WC2B 4AN
United Kingdom

Sponsor type

Research council

Website

Funders

Funder type

Government

Funder name

Department For International Development [DFID] (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Wellcome Trust (UK) ref: G1100699

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23223597

Publication citations

  1. Results

    Qian MB, Yap P, Yang YC, Liang H, Jiang ZH, Li W, Tan YG, Zhou H, Utzinger J, Zhou XN, Keiser J, Efficacy and safety of tribendimidine against Clonorchis sinensis., Clin. Infect. Dis., 2013, 56, 7, e76-82, doi: 10.1093/cid/cis1011.

Additional files

Editorial Notes