Opisthorchiasis Infections and Infestations Opisthorchiasis
Conditions
Interventions
Participants will be randomized to one of four treatment groups or a control group (given a placebo)
1. Praziquantel 30 mg/kg
2. Praziquantel 40 mg/kg
3
Sponsors
Swiss Tropical and Public Health Institute (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent signed by participant 2. Age 15-65 years 3. Able and willing to be examined by a study physician at the beginning of the study and 3 weeks after treatment 4. Able and willing to provide three stool samples at the beginning of the study and 3 weeks after treatment 5. Able and willing to provide 11 finger prick blood samples for PK studies 6. Infected with O. viverrini 7. Absence of major systemic illnesses as assessed by a medical doctor, upon initial clinical assessment 8. No known allergy to study medications
Exclusion criteria
Exclusion criteria: 1. No written informed consent 2. Presence of any abnormal medical condition, judged by the study physician 3. History of acute or severe chronic disease such as liver or renal disease 4. Recent use of anthelminthic drug (within past 4 weeks) 5. Pregnancy or breastfeeding 6. Administration of any investigational product or use of any investigational device within 30 days prior to praziquantel administration. Subjects who have used drugs that may affect thepharmacokinetics of praziquantel from 15 days before dosing until the last PK sample, e.g., phenytoin, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, oral ketoconazole 7. Consumption of substances known to be potent inhibitors or inducers of CYP P450s such as grapefruit juice, grapefruit juice containing products, and herbal remedies or dietary supplements containing St John?s Wort, in the two weeks before dosing 8. Attending other clinical trials during the study 9. Below 15 years of age 10. Negative diagnostic result for Opisthorchis 11. Allergy to praziquantel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure rate: measured 21 days post-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Egg reduction rate: measured 21 days post-treatment 2. Pharmacokinetic parameters: measured up to 24 hours post-treatment 3. Safety: measured 3 hours and 24 hours post-treatment | — |
Countries
Laos
Outcome results
None listed