This study aims to assess the efficacy, safety and acceptability of ascending doses of arpraziquantel compared to placebo 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 2-7 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
125
Tablets (dispersible) containing 150 mg arpraziquantel
Tablets containing no active pharmaceutical ingredient (Placebo Tablets)
Lao Tropical and Public Health Institute (Lao TPHI)
Vientiane, Laos
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.
Time frame: 14-21 days 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.
Time frame: 14-21 days after treatment
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 14-21days after treatment administration about the occurrence of AEs. AEs will be evaluated descriptively as the difference of proportion reported AEs before and after treatment.
Time frame: 3 hours, 24 hours and 14-21 days after treatment
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