Efficacy and Safety of Ascending Doses of Arpraziquantel in Children Infected With Opisthorchis Viverrini
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Apraziquantel.
- Who it may be relevant to
- Registry conditions: Opisthorchis Viverrini. Basic parameters: 6 years — 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Laos
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- Drug Apraziquantel
Tablets (dispersible) containing 150 mg arpraziquantel
Primary outcome measures
- Cure rate (CR) of arpraziquantel against O. viverrini [Time frame: 21-28 days after treatment]
Secondary outcome measures (2)
- Egg reduction rates (ERR) of arpraziquantel against O. viverrini [Time frame: 21-28 days after treatment]
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Laos · 1 center
- Lao Tropical and Public Health Institute (Lao TPHI) — Vientiane
Identifiers
NCT: NCT07262814 · ADORA-VI