An Open-label, Multicentre, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VaboremⓇ (Meropenem-Vaborbactam) in Paediatric Population With Suspected or Confirmed Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 38
- 主要终点
- Half-life (t1/2) of Meropenem
研究概览
简要总结
The goal of this clinical trial is to assess the pharmacokinetic (PK) and safety and tolerability of Vaborem (fixed combination of meropenem and vaborbactam) in the paediatric population aged from birth to < 18 years with suspected or confirmed Gram negative infections in need of hospitalisation and intravenous (IV) antibiotic administration.
All participants will receive Vaborem IV every 8 hours to treat the suspected or confirmed Gram negative infections for 10 up to 14 days; switch to stepdown oral antibiotic is allowed after a minimum of 3 days of Vaborem. PK sample collection will occur after at least 6 doses administration.
Participant's clinical conditions will be monitored during the entire duration of the hospitalization and during scheduled visit/s after the completion of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Written informed consent before initiation of any study-related procedures.
- •Male or female, from birth to < 18 years of age, inclusive.
- •Require hospitalization and a minimum of 3 days of IV antibiotic treatment for suspected or confirmed Gram negative infection as per Investigator's judgement.
- •Gram negative infection, according to diagnostic criteria for complicated urinary tract infection/acute pyelonephritis (cUTI/AP), complicated intra-Abdominal Infections (cIAI), Hospital-Acquired Pneumonia/Ventilator Associated Pneumonia (HAP/VAP), Blood-Stream Infection (BSI).
排除标准
- •History of any moderate or significant hypersensitivity or allergic reaction to beta-lactam antibiotics or to any component of the investigational medical product.
- •Gram negative infection that in the opinion of the Investigator is unlikely to respond to the study treatment.
- •In treatment with immunosuppressive agents, valproic acid, or probenecid.
研究组 & 干预措施
Investigational product arm
Single arm study. All participants enrolled will receive the investigational product.
干预措施: Meropenem plus vaborbactam (Drug)
结局指标
主要结局
Half-life (t1/2) of Meropenem
时间窗: Day 3
Maximum plasma concentration (Cmax) for Vaborbactam
时间窗: Day 3
Clearance (CL) of Vaborbactam
时间窗: Day 3
Maximum plasma concentration (Cmax) for Meropenem
时间窗: Day 3
Area under the concentration-time curve (AUC) for Vaborbactam
时间窗: Day 3
Area under the concentration-time curve (AUC) for Meropenem
时间窗: Day 3
Steady-state volume of distribution (Vss) of Meropenem
时间窗: Day 3
Steady-state volume of distribution (Vss) of Vaborbactam
时间窗: Day 3
Half-life (t1/2) of Vaborbactam
时间窗: Day 3
Clearance (CL) of Meropenem
时间窗: Day 3
次要结局
- Number of patients experiencing Treatment Emergent Adverse Events (TEAE)(From baseline (day 1) to the last follow up visit (up to day 30))