Efficacy and Safety of Ascending Doses of Arpraziquantel in Children Infected With Opisthorchis Viverrini (ADORA-VI)

Jennifer Keiser

Status and phase: Not yet enrolling; Phase 2

Conditions: Opisthorchis Viverrini

Treatments: Drug: Apraziquantel; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07262814

ADORA-VI

Details and patient eligibility

About

This study aims to assess the efficacy, safety and acceptability of ascending doses of arpraziquantel compared to placebo 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 2-7 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 2 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 2 to 7 years (i.e., 24 to 95 months).
• Bodyweight ≥ 10.0 kg
• 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 14-21 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.
• Being breastfed.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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125 participants in 5 patient groups, including a placebo group

Arpraziquantel 30 mg/kg

Experimental group

Description:

Treatment with a single dose arpraziquantel: 30 mg/kg, orally administered

Treatment:

Drug: Apraziquantel

Arpraziquantel 40 mg/kg

Experimental group

Description:

Treatment with a single dose arpraziquantel: 40 mg/kg, orally administered

Treatment:

Drug: Apraziquantel

Arpraziquantel 50 mg/kg

Experimental group

Description:

Treatment with a single dose arpraziquantel: 50 mg/kg, orally administered

Treatment:

Drug: Apraziquantel

Arpraziquantel 60 mg/kg

Experimental group

Description:

Treatment with a single dose arpraziquantel: 60 mg/kg, orally administered

Treatment:

Drug: Apraziquantel

Placebo

Placebo Comparator group

Description:

Placebo treatment, orally administered

Treatment:

Drug: Placebo