Liver fluke (Opisthorchis viverrini) infection Infections and Infestations
Conditions
Interventions
1. Dose finding 2a trial: Children aged 0 to 14 years will be randomized into 3 groups:
Group 1 will receive 50 mg
Group 2 will receive 100 mg
Group 3 2
Sponsors
Swiss Tropical and Public Health Institute (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients (older than 8 years) infected with O. viverrini (respectively: C. sinensis in PR China), as assessed by the presence of eggs in the stool 2. Able and willing to be examined by a study physician at the beginning of the study and at the end-of study (3 weeks post-treatment) 3. Able and willing to provide 2 stool samples at the beginning and end of study 4. Absence of major systemic illnesses, as assessed by the medical doctor, upon initial clinical assessment 5. Absence of psychiatric and neurological disorders 6. No known or reported hypersensitivity to tribendimidine 7. No known or reported history of chronic illness as cancer, diabetes, chronic heart, liver or renal disease 8. Signed written informed consent sheet 9. For females aged 12 years and above, not pregnant, as assessed by a female nurse (interview and pregnancy test), upon initial clinical assessment
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Presence of any abnormal medical condition, judged by the study physician. 3. Concurrent non-helminthic infectious disease as judged by the study clinician (for malaria, use rapid diagnostic test to diagnose). 4. History of acute or severe chronic disease 5. Known or reported psychiatric or neurological disorders 6. Use of praziquantel and other helminth treatment within the past three months 7. Attending other clinical trials during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| O. viverrini infection: cure rates and egg reduction rates | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events observed with tribendimidine and praziquantel 2. PK parameters of tribendimidine in patients infected with O. viverrini 3. Co-infection with soil-transmitted helminths (hookworm, A. lumbricoides, T. trichiura) | — |
Countries
Laos
Outcome results
None listed