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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Cure rate (CR) of arpraziquantel against O. viverrini
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Arpraziquantel 30 mg/kg
Treatment with a single dose arpraziquantel: 30 mg/kg, orally administered
干预措施: Apraziquantel (Drug)
Arpraziquantel 40 mg/kg
Treatment with a single dose arpraziquantel: 40 mg/kg, orally administered
干预措施: Apraziquantel (Drug)
Arpraziquantel 50 mg/kg
Treatment with a single dose arpraziquantel: 50 mg/kg, orally administered
干预措施: Apraziquantel (Drug)
Arpraziquantel 60 mg/kg
Treatment with a single dose arpraziquantel: 60 mg/kg, orally administered
干预措施: Apraziquantel (Drug)
Arpraziquantel 20 mg/kg
Treatment with a single dose arpraziquantel: 20 mg/kg, orally administered
干预措施: Apraziquantel (Drug)
结局指标
主要结局
Cure rate (CR) of arpraziquantel against O. viverrini
时间窗: 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.
次要结局
- Egg reduction rates (ERR) of arpraziquantel against O. viverrini(21-28 days after treatment)
- Safety and tolerability of the different arpraziquantel dosing regimens, and compared to placebo(3 hours, 24 hours, 21-28 days and 42 days after treatment)
研究者
Jennifer Keiser
Prof. Dr.
Swiss Tropical & Public Health Institute