Efficacy and Safety of Ascending Doses of Arpraziquantel in Children Infected With Opisthorchis Viverrini

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-7
SponsorJennifer Keiser

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

125 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Jennifer Keiser

Lead sponsor

Swiss Tropical & Public Health Institute

Sponsor institution

Lao Tropical and Public Health Institute

Collaborator