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 Peoples 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
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 Peoples 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 measure
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 (if study stopped)
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
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
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
Wellcome Trust (UK) ref: G1100699
Alternative name(s)
Wellcome
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23223597
Publication citations
-
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.