A Randomised, Single-Blinded Phase II Trial to Assess the Efficacy, Safety and Acceptability of Oxantel Pamoate in Comparison to Mebendazole for Trichuris Trichiura Infections in Children Aged 2-12 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Cure rate (CR) of oxantel pamoate single dose compared to mebendazole T. trichiura
研究概览
简要总结
This study aims to provide evidence on the efficacy, safety and acceptability of the new, chewable formulation of oxantel pamoate administered as a single dose or multiple doses, compared to mebendazole in children infected with T. trichiura. This study will involve children aged 2-12 years, since an infection with T. trichiura occurs often in children.
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
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 2 and 12 years.
- •Written informed consent signed by parents/caregivers (signature or thumbprint) and, for children aged 6-12 years, written assent from the child.
- •Agree to comply with study procedures, including provision of two stool samples at the baseline and at follow-up assessment 14-21 days after treatment, respectively.
- •At least two out of four Kato-Katz thick smears positive for T. trichiura at baseline.
- •Willing to be examined by a study physician prior to treatment.
排除标准
- •Presence or signs of major systemic illness or abnormal physical findings at screening, e.g. severe anaemia (Hb level <80 g/L according to WHO) upon initial clinical assessment.
- •Known allergy to study medication (i.e. oxantel pamoate, mebendazole or any of the excipients).
- •Use of anthelminthic drugs within 4 weeks before or during study period.
- •Being prescribed or taking concomitantly medication with known contraindication or drug interactions with the study medication.
- •Actively participating in other clinical trials during the study.
- •Pregnancy (female participants that report to have reached menarche
研究组 & 干预措施
Oxantel Single Dose
Treatment with oxantel pamoate (20 mg/kg), orally administered on day 0
干预措施: Oxantel Pamoate (Drug)
Oxantel Multiple Dose
Treatment with oxantel pamoate (20 mg/kg), orally administered on each of day 0, 1 and 2
干预措施: Oxantel Pamoate (Drug)
Mebendazole Single Dose
Mebendazole (500mg), orally administered on day 0
干预措施: Mebendazole (Drug)
结局指标
主要结局
Cure rate (CR) of oxantel pamoate single dose compared to mebendazole T. trichiura
时间窗: 14-21 days after treatment
CR will be calculated as the percentage of Trichuris trichiura egg-positive participants at baseline who become egg-negative after treatment.
次要结局
- Egg reduction rate (ERR) of oxantel pamoate single dose compared to mebendazole against T. trichiura(14-21 days after treatment)
- Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to oxantel single dose against T. trichiura(14-21 days after treatment)
- Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to mebendazole against T. trichiura(14-21 days after treatment)
- Cure rates (CRs) and egg reduction rates (ERRs) of oxantel pamoate compared to mebendazole against Ascaris lumbricoides and hookworm infections in co-infected participants(14-21 days after treatment)
- Number of adverse events (AE) to assess safety and tolerability of oxantel pamoate administered as a single dose or as multiple doses, and compared with mebendazole(3 hours, 24 hours (and 48 and 72h for the multiple dose treatment arm) and 14-21 days after treatment)
研究者
Jennifer Keiser
Prof. Dr.
Swiss Tropical & Public Health Institute