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NCT Number: NCT07262814

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

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.

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Key information

Age range

6 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Use of anthelminthic drugs within 4 weeks before or during study period.
  • Known allergy to study medications (i.e. praziquantel or any of the excipients).
  • Being prescribed or taking concomitantly medication with known contraindication or drug interactions with the study medication.
  • Concurrent participation in other clinical trials.

Treatment and study plan

Apraziquantel

Drug

Tablets (dispersible) containing 150 mg arpraziquantel

Primary outcomes

  1. Cure rate (CR) of arpraziquantel against O. viverrini

    Time frame: 21-28 days after treatment

    CRs will be calculated as the percentage of O. viverrini egg-positive participants at baseline who become egg-negative after treatment.

Secondary outcomes

  1. Egg reduction rates (ERR) of arpraziquantel against O. viverrini

    Time frame: 21-28 days after treatment

    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.

  2. Safety and tolerability of the different arpraziquantel dosing regimens, and compared to placebo

    Time frame: 3 hours, 24 hours, 21-28 days and 42 days after treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Keiser, PhD

CONTACT

[email protected]

+41 61 284 82 18

Sponsors and collaborators

Lead sponsor

Jennifer Keiser

Other

Collaborators

  • Lao Tropical and Public Health Institute

Registry information

Official study title

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

Acronym: ADORA-VI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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