About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Apraziquantel
Treatment groups
Sponsors and collaborators
Jennifer Keiser
Lead sponsor
Swiss Tropical & Public Health Institute
Sponsor institution
Lao Tropical and Public Health Institute
Collaborator