A Prospective, Multinational, Multicenter, Randomized, Sequential, Double-blind, Placebo-controlled, Phase 2a Clinical Trial to Assess the Safety and Pharmacokinetics of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex (ABC).
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 6
- 主要终点
- To assess the safety of a single-day treatment with OMN6 vs. matching placebo when coadministered with a background therapy of meropenem and colistin
研究概览
简要总结
This is a phase 2a, multinational, multicenter, double-blind, randomized, placebo-controlled, dose-ranging safety, tolerability and PK study in patients with HABP (Hospital Acquired Bacterial Pneumonia) or VABP (Ventilator Associated Bacterial Pneumonia) caused by ABC to identify safe and well-tolerated doses and to assess the PK profile of OMN6 in patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A signed informed consent form.
- •Male or female patients 18 years or older
- •A diagnosis of either a HABP or a VABP
- •ABC infection of the lower respiratory tract suspected based on a positive rapid testing of respiratory specimens
- •Women of childbearing potential (WOCBP) (i.e., not post-menopausal or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test before randomization.
- •Acute Physiology and Chronic Health Evaluation II (APACHE II) score between 10 and 24
排除标准
- •Moderate to severe reduction of renal function
- •Liver dysfunction
- •Evidence of septic shock
- •Acute respiratory distress syndrome.
- •Immunosuppressed patients (due to either immunosuppressant drugs or to any medical condition).
- •History of any known hypersensitivity to colistin or to carbapenems
- •Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the study data
研究组 & 干预措施
Placebo
Placebo on top of Meropenem and Colistin
干预措施: Placebo (Drug)
OMN6 treatment
OMN6 on top of Meropenem and Colistin
干预措施: OMN6 (Drug)
结局指标
主要结局
To assess the safety of a single-day treatment with OMN6 vs. matching placebo when coadministered with a background therapy of meropenem and colistin
时间窗: 28 day
Incidence of TEAE and SAEs by frequency, severity, relatedness, and outcome, clinical laboratory findings change from baseline, vital signs and ECGs change from baseline.
To asses the Cmax of OMN6 in patient population
时间窗: 1 day
Maximum Observed Plasma Concentration
To assess the t1/2 of OMN6 in patient population
时间窗: 1 day
Time to Half-life
To assess the Tmax of OMN6 in patient population
时间窗: 1 day
Time to Cmax
To assess the AUC of OMN6 in patient population
时间窗: 1 day
Area Under the Plasma Concentration-Time Curve
次要结局
未报告次要终点