A Randomized, Controlled, Evaluator-blinded, Multi-center, Study to Evaluate LYS228 Pharmacokinetics, Clinical Response, Safety and Tolerability in Patients With Complicated Urinary Tract Infection
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Plasma Pharmacokinetics (PK) of LYS228: The systemic (or total body) clearance from plasma following intravenous administration (CL)
研究概览
简要总结
The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of complicated urinary tract infections
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
A blinded evaluator will perform the safety and efficacy assessments
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients 18 to 85 years of age with suspected and/or bacteriologically documented complicated UTI judges by the investigator to be serious (required patient to be hospitalized for treatment with intravenous antibiotics)
排除标准
- •Urine Gram stain that demonstrated that a Gram-positive organism was present, or if urine culture results were available, demonstrated Gram- positive organisms were present at ≥10E5 CFU/mL
- •Urine culture result available at enrollment and demonstrating more than 2 different species of microorganisms regardless of the colony count
- •Urine culture result available demonstrating fungal UTI with colony count >10E3 CFU/mL
- •Patient had received prior antibiotics within 72 hours before the initiation of study therapy
- •Patients with estimated glomerular filtration rate < 30mL/min calculated based in study qualified formula
研究组 & 干预措施
LYS228
IV infusion
干预措施: LYS228 (Drug)
Standard of care
IV infusion of standard of care antibiotics for at least 5 days
干预措施: Standard of care therapy (Drug)
结局指标
主要结局
Plasma Pharmacokinetics (PK) of LYS228: The systemic (or total body) clearance from plasma following intravenous administration (CL)
时间窗: Day 5
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Plasma Pharmacokinetics (PK) of LYS228: The observed maximum plasma concentration following drug administration (Cmax)
时间窗: Day 5
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Urine Pharmacokinetics (PK) of LYS228: Renal Clearance (CLr)
时间窗: Day 5
Calculated based on LYS228 concentration in urine at different time points following drug administration on Day 5
Change from Baseline of the Clinical Response at Day 7
时间窗: Baseline, Day 7
Clinical success at 7 days after randomization determined by signs and symptoms of infection and the need for additional antibiotics
Plasma Pharmacokinetics (PK) of LYS228: Area Under the Plasma Concentration-time Curve from time zero to the end of dosing interval tau (AUCtau)
时间窗: Day 5
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Plasma Pharmacokinetics (PK) of LYS228: The time to reach the maximum concentration after drug administration (Tmax)
时间窗: Day 5
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Plasma Pharmacokinetics (PK) of LYS228: The amount of time in which the unbound drug concentration exceeds the minimum inhibitory concentration of the organism (%fT>MIC)
时间窗: Day 5
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Urine Pharmacokinetics (PK) of LYS228: The amount of drug eliminated in Urine from 0 hours up to 6 hours following intravenus administration (Ae0-6h)
时间窗: Day 5
Calculated based on LYS228 concentration in urine at different time points following drug administration on Day 5
Plasma Pharmacokinetics (PK) of LYS228: The volume of distribution at steady state following intravenous administration (Vss)
时间窗: Day 5
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Plasma Pharmacokinetics (PK) of LYS228: The terminal elimination half-life (T 1/2)
时间窗: Day 5
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
次要结局
- Change from Baseline of the Microbiological Response at Day 7(Baseline, Day 7)