Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura in Adolescents: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- Cure rate against Trichuris trichiura
研究概览
简要总结
The study rationale is to provide evidence on effective doses of moxidectin and/or moxidectin-albendazole in adolescents (16-18 years old) infected with Trichuris trichiura. The study will take place on Pemba Island, Tanzania.
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)
盲法说明
Participants will receive placebos. Outcome assessors and caregivers will not have access to the list of children allocated to each treatment arm.
入排标准
- 年龄范围
- 16 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged 16 to 18 years, inclusive
- •Written informed consent/assent signed from parent/guardian
- •Positive for T. trichiura by at least two slides of the quadruple Kato-Katz thick smears and infection intensities of at least 100 eggs per gram of stool (EPG)
- •Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and approximately three weeks after treatment (follow-up).
排除标准
- •Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, infection, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment.
- •Known or reported history of chronic illness such as HIV, acute or chronic hepatitis, cancer, diabetes, chronic heart disease or renal disease.
- •Prior treatment with anthelmintics (eg, diethylcarbamazine [DEC], suramin, ivermectin or albendazole) within 4 weeks before planned test article administration.
- •Received any investigational drugs or investigational devices within 4 weeks before administration of test article that may confound safety and/or efficacy assessments.
- •Known or suspected allergy to moxidectin, ivermectin or albendazole or other compounds related to these classes of medication.
- •Pregnant (urine testing) or breastfeeding women
研究组 & 干预措施
Moxidectin 24 mg + Albendazole
Three tablets of 8 mg of moxidectin ( = 24 mg) plus a single tablet of albendazole (400 mg)
干预措施: Moxidectin 24 mg + albendazole 400 mg (Drug)
Moxidectin 8 mg
A single tablet of 8 mg of moxidectin
干预措施: Moxidectin 8mg (Drug)
Moxidectin 8 mg + Albendazole
A single tablet of 8 mg of moxidectin plus a single tablet of albendazole (400 mg)
干预措施: Moxidectin 8 mg + albendazole 400 mg (Drug)
Moxidectin 16 mg
Two tablets of 8 mg of moxidectin ( = 16 mg)
干预措施: Moxidectin 16 mg (Drug)
Moxidectin 16 mg + Albendazole
Two tablets of 8 mg of moxidectin ( = 16 mg) plus a single tablet of albendazole (400 mg)
干预措施: Moxidectin 16 mg + albendazole 400 mg (Drug)
Moxidectin 24 mg
Three tablets of 8 mg of moxidectin ( = 24 mg)
干预措施: Moxidectin 24 mg (Drug)
Placebo
A single tablet of placebo
干预措施: Placebo (Other)
结局指标
主要结局
Cure rate against Trichuris trichiura
时间窗: 6 weeks
Conversion from being Trichuris trichiura-egg positive pre-treatment to egg negative post-treatment. Since this might be influenced by infection intensity, treatment groups will be equally balanced in terms of infection intensity by 2 levels of baseline infection intensity (light infections and moderate/heavy infections).
次要结局
- Egg Reduction Rate of hookworm(6 weeks)
- Number of adverse events at 5 time points(6 weeks)
- Egg Reduction Rate of the different drug regimens against Trichuris trichiura(6 weeks)
- Cure rate of the different drug regimens against Ascaris lumbricoides(6 weeks)
- Egg Reduction Rate of Ascaris lumbricoides(6 weeks)
- Cure rate against hookworm(6 weeks)
研究者
Jennifer Keiser
Principal Investigator
Swiss Tropical & Public Health Institute