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Efficacy, Safety and Acceptability of Ascending Doses of Arpraziquantel for Opisthorchis Viverrini Infections in Children Aged 6-7 Years: A Single-blind Randomized Dose-ranging Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 7
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Lao People's Democratic Republic
Lao Tropical and Public Health Institute (Lao TPHI)
RECRUITING
Vientiane
Contact Information
Primary
Jennifer Keiser, PhD
jennifer.keiser@swisstph.ch
+41 61 284 82 18
Time Frame
Start Date: 2026-07-22
Estimated Completion Date: 2026-10
Participants
Target number of participants: 125
Treatments
Experimental: Arpraziquantel 30 mg/kg
Treatment with a single dose arpraziquantel: 30 mg/kg, orally administered
Experimental: Arpraziquantel 40 mg/kg
Treatment with a single dose arpraziquantel: 40 mg/kg, orally administered
Experimental: Arpraziquantel 50 mg/kg
Treatment with a single dose arpraziquantel: 50 mg/kg, orally administered
Experimental: Arpraziquantel 60 mg/kg
Treatment with a single dose arpraziquantel: 60 mg/kg, orally administered
Experimental: Arpraziquantel 20 mg/kg
Treatment with a single dose arpraziquantel: 20 mg/kg, orally administered
Related Therapeutic Areas
Sponsors
Leads: Jennifer Keiser
Collaborators: Lao Tropical and Public Health Institute

This content was sourced from clinicaltrials.gov

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