Liver fluke infections (Clonorchis sinesis) Infections and Infestations Clonorchiasis
Conditions
Interventions
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
Sponsors
Medical Research Council (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
China
Outcome results
None listed