A Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of C.Diff in Patients With a Diagnosis of a Lower Respiratory Tract Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 413
- 试验地点
- 3
- 主要终点
- Percentage of Patients With Clostridium Difficile Infection at 4- Weeks of Follow-up.
研究概览
简要总结
A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of Clostridium difficile Infection (CDI) in Hospitalized Patients receiving IV ceftriaxone with a Diagnosis of a Lower Respiratory Tract Infection (LRTI).
详细描述
This is a Phase 2b, randomized, double-blind, placebo controlled, parallel-group, multi-center proof-of-concept study to assess the potential of SYN-004 in the prevention of CDI and the unwanted side effects of IV antibiotic treatment in at risk patients who are hospitalized for LRTI and receiving IV ceftriaxone alone or in combination with a macrolide. Subjects will be 50 years or older. The entire duration of the study may be up to 59 days. All patients will be evaluated for the occurrence of CDI and AAD by testing according to local diagnostic standards and monitoring for diarrhea (3 or more unformed stools per 24 hour period).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Expected minimum hospital stay of 5 days
- •Expected ≥5 day course of intravenous (IV) ceftriaxone alone or in combination with a macrolide
- •Clinical diagnosis of moderate to severe lower respiratory tract infection consisting of signs and symptoms of a lower respiratory tract infection and Pneumonia Severity Index (PSI/PORT) score for CAP of 90-130, inclusive. Evidence of a new or progressive infiltrate on chest x-ray is recommended.
排除标准
- •Presence of a diarrheal illness within 72 hours prior to randomization
- •Current treatment for CDAD or ongoing active CDI, as evidenced by clinical signs of diarrhea along with the presence of toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool
- •Number of previous CDAD episodes >1 within 12 weeks of randomization and no C. difficile infection (CDI) within 4 weeks of randomization
- •Use of antibiotics within 1 month of start of study drug except for the current illness.
研究组 & 干预措施
SYN-004
SYN-004 150 mg
干预措施: SYN-004 (Drug)
Placebo
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Patients With Clostridium Difficile Infection at 4- Weeks of Follow-up.
时间窗: Day 1 to the 4 week Follow-up Visit.
Percentage of subjects with CDI, based on the protocol definition of CDI (defined as 3 or more unformed stools per 24 hour period and a stool sample being positive for C. difficile toxin A and/or B \[or their respective genes, tcdA and/or tcdB\], based on the clinical site local laboratory results) from Day 1 to the 4-week Follow-up Visit in the SYN-004 treatment group compared to the placebo group, imputing early termination without CDI as not being treatment failures.
次要结局
未报告次要终点