A Phase 3 Study to Evaluate Cefepime-taniborbactam Compared to Meropenem in Adults With Ventilator Associated Bacterial Pneumonia (VABP) or Ventilated Hospital Acquired Bacterial Pneumonia (vHABP)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 316
- 主要终点
- ACM through Study Day 14
研究概览
简要总结
This is a Phase 3, randomized, multicenter, double-blind, non-inferiority study to evaluate the efficacy and safety of cefepime-taniborbactam compared to meropenem in patients ≥ 18 years of age with ventilated HABP or VABP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
A double-blind design is used to maintain blinding for all personnel involved with the evaluation of patient efficacy and safety during the study. With the exception of the unblinded pharmacist or designee, unblinded study monitors and scientists conducting plasma assays and analyses for PK assessments, the sponsor, investigator, patient, and study site staff, will remain blinded to study drug.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, ≥18 years of age.
- •The patient or patient's legally authorized/acceptable representative (LAR) has voluntarily signed and dated the IRB/IEC approved ICF
- •Meets the clinical diagnosis of ventilated HABP or VABP
- •Have at least one of the following clinical criteria:
- •New onset or worsening of pulmonary symptoms and signs
- •New onset or worsening of purulent respiratory secretions
- •Need for acute changes in ventilator support
- •Have at least one of the following clinical criteria:
- •Documented fever (defined as body temperature ≥ 38°C [100.4°F]
- •Hypothermia (defined as body temperature ≤ 35°C [95°F])
- •White blood cell (WBC) ≥10,000 cells/mm3 or ≤4,500 cells/mm3
- •>15% immature neutrophils (bands).
- •Have new or worsening infiltrate on a pulmonary imaging study that is consistent with bacterial pneumonia within 48 hours prior to randomization.
- •Have a lower respiratory tract specimen sent for Gram stain and quantitative culture within 36 hours prior to the first dose of study drug.
排除标准
- •Receipt of effective antibacterial treatment for pneumonia for a continuous duration of >24 hours during the previous 72 hours prior to randomization.
- •Pneumonia known or suspected to be caused by:
- •A bacterial pathogen resistant to meropenem, as assessed by susceptibility testing or against which either one or both study drugs lack activity
- •Viruses, atypical bacteria, or fungi
- •Use of non-study systemic gram-negative therapy.
- •Confounding respiratory conditions.
- •Receiving extracorporeal membrane oxygenation (ECMO).
- •Patients with refractory septic shock.
- •Active immunosuppression.
- •Has a history of serious hypersensitivity (e.g., anaphylaxis), serious allergy, or any serious reaction to cephalosporin, penicillin, carbapenem, or other β-lactam antibiotics.
- •Female patients who are pregnant.
- •Patients with eGFR <10 mL/min/1.73 m2 or are receiving or starting renal replacement therapy or expected to require renal replacement therapy during the treatment phase of the study.
研究组 & 干预措施
Cefepime-taniborbactam
cefepime-taniborbactam (2g/0.5g) IV every 8 hours.
干预措施: Cefepime-taniborbactam (Drug)
Meropenem
Comparator: meropenem (2g) IV every 8 hours.
干预措施: Meropenem (Drug)
结局指标
主要结局
ACM through Study Day 14
时间窗: Evaluated on Day 15
The primary endpoint is ACM, a binary variable, through Study Day 14. The primary endpoint is evaluated in the ITT population and is based on the patient's survival status through Study Day 14.
次要结局
- ACM through Study Day 28(Evaluated on Day 29-33)
- Safety Outcomes(From first dose up to Day 33)