A Randomized, Controlled, Evaluator-blinded, Multi-center Study to Evaluate LYS228 Pharmacokinetics, Clinical Response, Safety, and Tolerability in Patients With Complicated Intra-abdominal Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Plasma Pharmacokinetics (PK) of LYS228: The Terminal Elimination Half-life (T1/2)
研究概览
简要总结
The purpose of the study was to evaluate whether LYS228 can be developed for the treatment of complicated intra-abdominal infections.
It was planned that LYS228 exposure across patients with varying renal function would be evaluated during the study to confirm that LYS228 concentrations are predicted to be adequate to treat the patient population. It was planned that the PK exposure of the initial 8 patients would be analyzed.
PK analysis was not conducted as per protocol the first analysis required 8 patients.
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 performed the safety and efficacy assessments
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
- •Male and female patients 18 to 85 years of age with visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis including at least one inclusionary diagnosis during surgical intervention.
- •Exclusion Criteria
- •Any of the excluded diagnoses: abdominal wall abscess, small bowel obstruction, traumatic bowel perforation undergoing surgery within 12 hours, perforation of gastroduodenal ulcer with surgery within 24 hours, an intra-abdominal process that is not likely caused by infection.
- •Pre-operative treatment of any duration with non-study Drug systemic antibiotic therapy for peritonitis or abscess is not allowed unless certain criteria are met.
- •Concomitant bacterial infection at time of enrollment requiring non-Study Drug antibiotics and that may interfere with the evaluation of clinical response to the study antibiotic.
- •Known non-abdominal source of infection, including endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to enrollment.
- •Patient has an Acute Physiology and Chronic Health Evaluation II (APACHE II) score > 30 or is considered, in the judgement of the investigator, unlikely to survive 4 weeks (e.g. rapidly progressive terminal illness, including septic shock).
- •Patients that meet sepsis criteria as defined by the quick sequential sepsis-related organ failure assessment (qSOFA).
- •Women of child-bearing potential unless they are using highly effective methods of contraception during dosing and for 7 days after stopping study treatment.
排除标准
- 未提供
研究组 & 干预措施
LYS228
IV infusion every 6 hours for at least 5 days
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 Terminal Elimination Half-life (T1/2)
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 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
Clinical Success at Day 28
时间窗: Day 28
Clinical success is defined as resolution, or substantial improvement (i.e. reduction of severity of all baseline signs and symptoms and worsening of none) of all or most baseline signs and symptoms of cIAI infection without the need for additional antibiotic therapy other than any oral antibiotics given to complete treatment at home following discontinuation of Study Drug and no drainage or surgical reintervention required 96 hours after the start of Study Drug.
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
Plasma Pharmacokinetics (PK) of LYS228: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the 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 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
次要结局
- Microbiological Response at Day 28(Day 28)
- Number of Patients With Adverse Events(Daily)