AN OPEN-LABEL, RANDOMIZED, MULTI-CENTER, ACTIVE-CONTROLLED STUDY TO ESTIMATE THE EFFICACY AND SAFETY OF CEFTAZIDIME-AVIBACTAM (CAZ-AVI) VERSUS BEST AVAILABLE TREATMENT (BAT) IN THE TREATMENT OF INFECTIONS DUE TO CARBAPENEM-RESISTANT GRAM-NEGATIVE PATHOGENS IN CHINESE ADULTS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 60
- 试验地点
- 35
- 主要终点
- Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit - Microbiologically Modified Intent-to-Treat (mMITT) Analysis Set
研究概览
简要总结
This is an open-label, randomized, multi-center, interventional, active-controlled Phase 4 study to evaluate the efficacy and safety of CAZ-AVI versus BAT in the treatment of infected participants with selected infection types (Hospital Acquired Pneumonia [HAP] (including Ventilator-Associated Pneumonia [VAP]); Complicated Urinary-Tract Infection [cUTI]; Complicated Intra-Abdominal Infection [cIAI]; Bloodstream Infection [BSI]) due to carbapenem-resistant Gram-negative pathogens in China.This study will be an estimation study. The statistical inference will be based on point estimate and confidence interval.
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
- None
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
- •Participant must have a diagnosis of an infection (HAP/VAP, cUTI, cIAI, BSI) due to confirmed carbapenem-resistant aerobic Gram-negative pathogens, requiring administration of IV antibacterial therapy
- •Participant who had received appropriate prior empiric antibacterial therapy for a carbapenem-resistant pathogen must meet at least 1 of the following criteria: no or no more than 24h; worsening of objective symptoms or signs after at least 48 hours of antibacterial therapy; no change of objective symptoms or signs after at least 72 hours of antibacterial therapy.
- •Capable of giving signed informed consent
排除标准
- •Other medical or psychiatric condition may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •Participant is expected to require more than 21 days of treatment
- •Participants who need more than 3 systemic antibiotics as part of best available treatment (BAT)
- •Previous administration with an investigational drug within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
- •Participant is pregnant or breastfeeding.
- •Acute Physiology and Chronic Health Evaluation (APACHE) II score >30 or <10 using the most recent available data.
研究组 & 干预措施
CAZ-AVI
ceftazidime 2g plus avibactam 0.5g
干预措施: Zavicefta, Ceftazidime-Avibactam (Drug)
Best Available Treatment
Based on investigative site practice and local epidemiology and guideline
干预措施: Best Available Treatment (Drug)
结局指标
主要结局
Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit - Microbiologically Modified Intent-to-Treat (mMITT) Analysis Set
时间窗: At TOC visit (From Day 21 up to Day 24)
Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e, complicated intra-abdominal infection \[cIAI\], complicated urinary-tract infection \[cUTI\], hospital-acquired pneumonia/ventilator-associated pneumonia \[HAP/VAP\] or bloodstream infection \[BSI\]) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response was assessed by the independent adjudication committee. 95 percent (%) confidence interval (CI) was calculated using Jeffrey's method.
次要结局
- Percentage of Participants With Clinical Cure at TOC Visit - Microbiologically Evaluable (ME) Analysis Set(At TOC visit (From Day 21 up to Day 24))
- Percentage of Participants With Clinical Cure at End of Treatment (EOT) Visit -mMITT Analysis Set(At EOT visit (up to 24 hours after the last infusion on Day 14))
- Percentage of Participants With Clinical Cure at EOT Visit - ME Analysis Set(At EOT visit (up to 24 hours after the last infusion on Day 14))
- Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit - mMITT Analysis Set(At TOC visit (From Day 21 up to Day 24))
- Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit - ME Analysis Set(At TOC visit (From Day 21 up to Day 24))
- Percentage of Participants With Favorable Per-Participant Microbiological Response at EOT Visit - mMITT Analysis Set(At EOT visit (Up to 24 hours after last infusion on Day 14))
- Percentage of Participants With Favorable Per-Participant Microbiological Response at EOT Visit - ME Analysis Set(At EOT visit (Up to 24 hours after last infusion on Day 14))
- Percentage of Participants With Favorable Per-Pathogen Microbiological Response at TOC Visit - mMITT Analysis Set(At TOC visit (From Day 21 up to Day 24))
- Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT Visit - mMITT Analysis Set(At EOT visit (Up to 24 hours after last infusion on Day 14))
- Percentage of Participants Who Died Due to Any Cause Until Day 28(From first dose of study intervention (Day 1) up to Day 28)
- Number of Participants With Treatment-Emergent Adverse Events(From start of study treatment on Day 1 up to 32 days after the last dose of study intervention (Up to 46 days))
- Number of Participants With Discontinuation Due to Adverse Events(From start of study treatment on Day 1 up to 32 days after the last dose of study intervention (Up to 46 days))
- Number of Participants With Potentially Clinically Significant Post-baseline Hematology Values(From first dose of study treatment (Day 1) until TOC (Up to Day 24))
- Number of Participants With Potentially Clinically Significant Post-baseline Clinical Chemistry Values(From first dose of study treatment (Day 1) until TOC (Up to Day 24))