Opisthorchis Viverrini
Conditions
Brief summary
This study aims to assess the efficacy, safety and acceptability of ascending doses of arpraziquantel in children infected with Opisthorchis viverrini. The primary objective is to determine the dose-response relationship in terms of cure rate. This study will involve children aged 6-7 years, since O. viverrini infections often occur in pre-school and school-aged children, and this group is largely left untreated in current public health programs.
Interventions
DRUGApraziquantel
Tablets (dispersible) containing 150 mg arpraziquantel
Sponsors
Jennifer Keiser
Lao Tropical and Public Health Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Aged 6 to 7 years (i.e., 72 to 95 months). * Written informed consent signed by parents/caregivers (signature or thumbprint). * Agree to comply with study procedures, including provision of two stool samples at baseline and at follow-up assessment 21-28 days after treatment, respectively. * Willing to be examined by a study physician prior to treatment. * At least two slides of the quadruple Kato-Katz thick smears positive for O. viverrini.
Exclusion criteria
* Presence or signs of major systemic illness, e.g. severe anaemia (haemoglobin level of \< 80 g/L according to WHO) upon initial clinical assessment. * Known or suspected infection with Taenia solium (cysticercosis). * Known or suspected acute schistosomiasis. * Abnormal liver and kidney function. * Use of anthelminthic drugs within 4 weeks before or during study period. * Known allergy to study medications (i.e. praziquantel or any of the excipients). * Being prescribed or taking concomitantly medication with known contraindication or drug interactions with the study medication. * Concurrent participation in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure rate (CR) of arpraziquantel against O. viverrini | 21-28 days after treatment | CRs will be calculated as the percentage of O. viverrini egg-positive participants at baseline who become egg-negative after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Egg reduction rates (ERR) of arpraziquantel against O. viverrini | 21-28 days after treatment | Eggs per gram of stool (EPG) will be assessed by calculating the mean egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of 24. Geometric and arithmetic mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. |
| Safety and tolerability of the different arpraziquantel dosing regimens, and compared to placebo | 3 hours, 24 hours, 21-28 days and 42 days after treatment | Participants will be monitored at the site for 3 hours following treatment for any acute adverse events (AEs). Participants will be interviewed 3 hours and 24 hours after treatment, as well as 21-28 days and 42 days after treatment administration about the occurrence of AEs. AEs will be evaluated descriptively as the difference of proportion reported AEs before and after treatment. |
Countries
Laos
Contacts
CONTACTJennifer Keiser, PhD
Outcome results
None listed