NCT01644643已完成3 期
An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 345
- 试验地点
- 1
- 主要终点
- Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set
研究概览
简要总结
To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections.
详细描述
An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be ≥18 and ≤90 years of age
- •Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after
- •Patient has a ceftazidime-resistant Gram negative pathogen that was isolated from an appropriate culture within 5 days prior to study entry (ie, within 5 days prior to Screening; the study-qualifying culture), which was determined to be the causative agent of the entry infection
排除标准
- •Patient has an APACHE II score >30 (cIAI patients only)
- •Patient has an infection due to Gram negative pathogen that is unlikely to respond to CAZ-AVI treatment (eg, Acinetobacter spp., Stenotrophomonas spp.)
- •Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant Patient is immunocompromised
- •Patient has a rapidly progressive or terminal illness with a high risk of mortality due to any cause, including acute hepatic failure, respiratory failure or severe septic shock such that they are unlikely to survive the 4- to 5-week study period.
研究组 & 干预措施
Ceftazidime - Avibactam ( CAZ-AVI)
Experimental
IV treatment
干预措施: Ceftazidime - Avibactam ( CAZ-AVI) (Drug)
Ceftazidime - Avibactam ( CAZ-AVI)
Experimental
IV treatment
干预措施: Metronidazole (Drug)
Best Available Therapy
Active Comparator
IV treatment
干预措施: Best Available Therapy (Drug)
结局指标
主要结局
Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set
时间窗: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Proportion of patients with clinical cure at the TOC visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
次要结局
- Clinical Response at End of Treatment (EOT) in mMITT Analysis Set.(28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.)
- Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set(cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization)
- Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set(At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization)
- Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set.(28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.)
- Clinical Response at TOC in EME at TOC Analysis Set.(6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.)
- Clinical Response at FU1 in EME at FU1 Analysis Set.(cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization)
- Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set(6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.)
- Clinical Response at FU2 in EME at FU2 Analysis Set(At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization)
- Per-patient Microbiological Response at EOT in mMITT Analysis Set(28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.)
- Per-patient Microbiological Response at TOC in mMITT Analysis Set(6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.)
- Per-patient Microbiological Response at FU1 in mMITT Analysis Set(cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization)
- Per-patient Microbiological Response at FU2 in mMITT Analysis Set(At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization)
- Per-patient Microbiological Response at EOT in EME at EOT Analysis Set(28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.)
- Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set(6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.)
- Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set(6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.)
- Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set(cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization)
- Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set(28 hours after completion of last infusion of study therapy.Duration of study therapy was 5 to 21 days.)
- Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set(6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.)
- Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set(At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization)
- Per-patient Microbiological Response at TOC in EME at TOC Analysis Set(6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.)
- Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set(cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization)
- Per-patient Microbiological Response at FU2 in EME at FU2 Analysis Set(At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization)
- Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set(28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.)
- Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set(6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.)
- Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set(cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization)
- Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set(At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization)
- Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set(28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.)
- Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set(6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.)
- Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set(cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization)
- Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set(At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization)
- Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set(6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.)
- Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set(6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.)
- The Reason for Treatment Change/Discontinuation in mMITT Analysis Set(From first infusion to last infusion of study therapy. Duration of study therapy was 5 to 21 days.)
- The 28 Days All Cause Mortality Rate in mMITT Analysis Set(From first infusion to Day 28)
- The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set(From first infusion to Day 28)
- Plasma Concentrations for Ceftazidime and Avibactam - cIAI in PK Analysis Set(Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug)
- Plasma Concentrations for Ceftazidime and Avibactam - cUTI in PK Analysis Set(Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug)
研究者
研究点 (1)
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