Opisthorchis felineus infection Infections and Infestations Opisthorchiasis
Conditions
Interventions
Patients will be randomized using block randomization to one of five groups:
Intervention group 1: Participants receive praziquantel 20 mg/kg BW (body weight) by single oral daily dose
Intervention gr
Sponsors
Siberian State Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent signed by participant prior to any study procedures 2. Patients 18-65 years and infected with Opisthorchis felineus as assessed by the presence of eggs in the stool 3. 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) 4. Able and willing to provide 2 stool samples at the beginning and end of study 5. Absence of major systemic illnesses, as assessed by the medical doctor, upon initial clinical assessment 6. Absence of psychiatric and neurological disorders 7. No known or reported hypersensitivity to praziquantel 8. No known or reported history of chronic illness as cancer, diabetes, chronic heart, liver or renal disease
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. History of acute or severe chronic disease 7. Known or reported psychiatric or neurological disorders 8. Administration of any investigational product or use of any investigational device within 30 days prior to praziquantel administration 9. Subjects who have used drugs that may affect the pharmacokinetics 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 10. 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 11. Attending other clinical trials during the study 12. Negative diagnostic result for Opisthorchis felineus 13. Allergy to praziquantel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure rate (i.e. conversion from being Opisthorchis felineus egg positive pre-treatment to egg negative post-treatment) on 18-25 days of the follow-up. The parasitological study will be used for the confirmation of the Opisthorchis felineus infection (microscopy of stool, quantitative analysis with PARASEP technique). For the post-treatment point two stool samples on two different days will be collected and analysed | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Egg reduction rate against Opisthorchis felineus infection assessed post-treatment assessed pre-treatment to post-treatment on 18-25 days of the follow-up. The parasitological study will be used for the assessment of the intensity of Opisthorchis felineus infection (microscopy of stool, qualitative analysis with PARASEP technique). For the post-treatment point two stool samples on two different days will be collected and analysed 2. Pharmacokinetic parameters: drug concentrations measured at 0, 0.5, 1, 1.5, 2, 2.5, 3, 6, 8, 12, 24 hours (single doses) and 0, 1, 2, 4, 5, 6, 7, 8, 10, 12, 24 hours (multiple doses) post-dosing | — |
Countries
Russian Federation
Outcome results
None listed