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.
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.
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.
Parallel
Apraziquantel
DrugTablets (dispersible) containing 150 mg arpraziquantel
Cure rate (CR) of arpraziquantel against O. viverrini
CRs will be calculated as the percentage of O. viverrini egg-positive participants at baseline who become egg-negative after treatment.
Egg reduction rates (ERR) of arpraziquantel against O. viverrini
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
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.
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Jennifer Keiser
Lead sponsor
Swiss Tropical & Public Health Institute
Sponsor institution
Lao Tropical and Public Health Institute
Collaborator