Arpraziquantel in children 6–7 years old with Opisthorchis viverrini infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 study evaluates ascending doses of arpraziquantel in children aged 6–7 with Opisthorchis viverrini infection to determine the dose-response relationship for cure and to monitor safety and tolerability. Participants provide two stool samples at baseline and 21–28 days post-treatment and undergo physician assessments. Eligibility requires confirmed infection by stool testing and absence of major systemic illnesses or recent anthelminthic use. Exclusion criteria include liver or kidney dysfunction, certain parasitic infections, and known allergies to the drug or excipients. The trial is led by Jennifer Keiser with collaboration from Lao Tropical and Public Health Institute, at Lao TPHI in Vientiane.

Why it matters

Who can join: the full rules

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.

Where it's running

• Lao Tropical and Public Health Institute (Lao TPHI)
  Vientiane, Laos Recruiting

Study contacts

• Study coordinator: Jennifer Keiser, PhD
• Email: jennifer.keiser@swisstph.ch
• Phone: +41 61 284 82 18

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.