Efficacy and Safety of Mino-Lok Therapy (MLT) in Combination With Systemic Antibiotics in the Treatment of Catheter-Related or Central Line-Associated Bloodstream Infection
试验速览
- 阶段
- 3 期
- 入组人数
- 144
- 试验地点
- 22
- 主要终点
- Time to a catheter failure event.
研究概览
简要总结
This is a Phase 3, multi-center, randomized, open-label, assess-blind study to determine the efficacy and safety of MLT, a novel antibiotic lock therapy that combines minocycline with edetate disodium in 25% ethanol solution as an adjuctive therapy for the treatment of catheter-related or central line associated bloodstream infection (CRBSI/CLABSI).
Approximately 144 subjects who have been diagnosed with CRBSI/CLABSI and who meet all necessary criteria for the study will be randomized in a 1:1 ratio to 1 of 2 treatment arms:
- MLT Arm: Mino-Lok therapy; or
- Control Arm: Antibiotic lock (±heparin). The antibiotic lock (ALT) should be comprised of the best available therapy at the sites based on standard institutional practices or recommendations from the Infectious Diseases Society of America (IDSA) guidelines.
详细描述
This is a Phase 3, multi-center, randomized, double-blind study to determine the efficacy and safety of MLT, a novel antibiotic lock therapy that combines minocycline with edetate disodium in 25% ethanol solution.
Mino-Lok Therapy is being developed as an adjunctive therapy for the treatment of catheter-related or central line associated bloodstream infection (CRBSI/CLABSI) in combination with appropriate systemic antibiotic(s), to preserve central venous access and to avoid the complications and morbidities associated with catheter removal and reinsertion.
Approximately 144 subjects who have been diagnosed with CRBSI/CLABSI and who meet all necessary criteria for the study will be randomized in a 1:1 ratio to 1 of 2 treatment arms:
- MLT Arm: MLT + SOC intravenous (IV) antibiotic therapy; or
- Control Arm (subjects randomized to the Control Arm will receive treatment based on the type and virulence of the infecting organism as documented by the Investigator prior to randomization): The antibiotic lock should be comprised of the best available therapy at the sites. Prior to randomization, the Investigator at each site will determine the antibiotic used in the lock, the dose, the dwell time, and the number of days of administration (minimum of 7 days) based on standard institutional practices or recommendations from the Infectious Diseases Society of America (IDSA) guidelines. In the event that the subject is being treated with more than 1 systemic SOC IV antibiotic, the Investigator will specify a single antibiotic that should be used for the antibiotic lock. It is acceptable for the SOC antibiotic lock to differ from the SOC IV antibiotics, as necessary per local SOC.
All infecting organism types are permitted (eg, S. aureus, S. epidermidis, Candida spp., Pseudomonas aeruginosa). Randomization will be stratified by type of CVC, presence of neutropenia, and by virulence of the infecting organism.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Standard of Care
Antibiotic lock + standard of care antibiotics. The standard of care antibiotic will be chosen by the investigator at the time of the infection.
干预措施: Antibiotic lock (Drug)
Mino-Lok Therapy (MLT)
Standard of care plus MLT. MLT contains minocycline with EDTA and ethanol.
干预措施: Mino-Lok (Drug)
结局指标
主要结局
Time to a catheter failure event.
时间窗: 6 weeks
The time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6) in the Intent-to-Treat (ITT) Population.
次要结局
- Proportion of subjects with overall success in the MITT and CE populations.(6 weeks)
- Microbiological eradication(6 weeks)
- All-cause mortality(6 weeks)
- Time to catheter failure in the MITT and CE Populations.(6 weeks)
- Clinical Cure(6 Weeks)
- Safety and Tolorability(6 Weeks)