Efficacy and Safety of Moxidectin in Comparison to Ivermectin Against Strongyloides Stercoralis Infection in Adults: a Randomized Controlled Non-inferiority Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 332
- 试验地点
- 1
- 主要终点
- Cure Rate Against Strongyloides Stercoralis
研究概览
简要总结
The study is an extension to the study StrongMoxi NCT04056325 and entails modifications based on the outcome of NCT04056325 part A.
The study is a phase 3, double-blinded and randomized clinical trial conducted in Cambodia. It aims at providing evidence on efficacy, safety and pharmacokinetic measures of 8 mg of moxidectin compared to 200 μg/kg ivermectin in adults infected with S. stercoralis. The efficacy of the treatment will be assessed by collecting three stool samples once per-treatment and once 21-28 days post-treatment. The stool samples will be analyzed by a quantitative duplicate Baermann assay.
详细描述
The study is a phase 3 trial and will determine the efficacy and safety of:
8 mg of moxidectin in comparison to the standard treatment dose of ivermectin (200 μg/kg) in adults infected with S. stercoralis and to measure moxidectin disposition in adults using a microsampling device.
Our primary objective is to demonstrate non-inferiority in terms of cure rate (CR) against S. stercoralis in adults of an oral 8 mg of moxidectin compared to 200 μg/kg of ivermectin.
The secondary objectives of the trial are:
- to evaluate the safety and tolerability of moxidectin
- to compare the larval reduction rate (LRR) of the two different treatment groups against S. stercoralis
- to evaluate the CRs of the different treatment drugs and regimens against soil-transmitted helminths (STH) co-infections.
- to investigate potential extended effects on follow-up helminth prevalence at 42-49 and 63-70 days post-treatment
- to relate socioeconomic characteristics (SES), access to sanitation, water facilities, hygiene to baseline infection intensity.
- to determine the larval excretion pattern till day 70 in the moxidectin treatment arm, determined at every second day between day zero and 70 post-treatment in a subset of 50 adults.
- to determine the origin of the remaining worm burden after treatment to treatment failure and reinfection based on genetic profiling.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blinded (Participant and Care provider) Additionally, the principal investigator and the statistician will be blinded.
PK substudy is single-blinded (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18-65 years)
- •Infected with S. stercoralis (positive)
- •Absence of major systemic illnesses
- •Written informed consent
排除标准
- •Any abnormal medical conditions or chronic disease
- •Negative diagnostic result for S. stercoralis
- •No written informed consent by the individual.
- •Pregnant and lactating women.
- •Recent use of an anthelmintic drug (within past 4 weeks)
- •Attending other clinical trials during the study
- •Known allergy to study medications (i.e. moxidectin, ivermectin)
- •Currently taking medications with known interaction (i.e. for warfarin)
研究组 & 干预措施
Moxidectin
8 mg Moxidectin at day 0 administered orally
干预措施: Placebo (Drug)
Moxidectin
8 mg Moxidectin at day 0 administered orally
干预措施: Moxidectin 2 mg (Drug)
Ivermectin
200 ug/kg Ivermectin at day 0 administered orally
干预措施: Ivermectin 3 mg (Drug)
Ivermectin
200 ug/kg Ivermectin at day 0 administered orally
干预措施: Placebo (Drug)
结局指标
主要结局
Cure Rate Against Strongyloides Stercoralis
时间窗: 14-21 days after treatment
The conversion from being larvae positive pre-treatment to larvae negative post-treatment, or cure rate (CR).
次要结局
- CRs Against Concomitant Soil-transmitted Helminth Infections - Trichuris Trichiura(14-21 days after treatment)
- Larvae Reduction Rate (LRR) Against Strongyloidiasis Stercoralis(14-21 days after treatment. The originally planned follow-ups at 42-49 days and 63-70 days as well as the sample collection every second day between day 0 and day 70 (Moxidectin arm, n=50) was not performed.)
- CRs Against Concomitant Soil-transmitted Helminth Infections - Ascaris Lumbricoides(14-21 days after treatment)
- CRs Against Concomitant Soil-transmitted Helminth Infections - Hookworm(14-21 days after treatment)
- Number of Participants Reporting Adverse Events(2-3 hours, 24 hours and 14-21 days after treatment. The originally planned follow-ups at 42-49 days and 63-70 days after treatment were not conducted.)
研究者
Jennifer Keiser
Prof. Jennifer Keiser, PhD
Swiss Tropical & Public Health Institute