CTRI/2014/05/004622进行中（未招募）3 期
Phase III, Randomized, Multicentre, Double-blind, Double-dummy,Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam (CAZ-AVI) Versus Meropenem in the Treatment of Nosocomial Pneumonia (NP) Including Ventilator-Associated Pneumonia (VAP) in Hospitalised Adults
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,600
- 试验地点
- 9
- 主要终点
- The proportion of patients with clinical cure in the clinically modified intent-to-treat and clinically evaluable analysis sets (co-primary analyses)
研究概览
简要总结
Short description of the primary purpose of the protocol, including a brief statement of the study hypothesis. Include publication/s details (link/reference), if any. This is a prospective, randomized, multicenter, double-blind, double-dummy parallel-group, comparative study to determine the efficacy, safety, and tolerability of CAZ-AVI versus meropenem in the treatment of adults with NP, including Ventilator Associated Pneumonia.
The following hypotheses will be assessed during this study: • Intravenous CAZ-AVI will demonstrate clinical efficacy comparable with that of IV meropenem as treatment for patients with NP • The safety and tolerability profile of CAZ-AVI administered intravenously is acceptable.
This study will randomize 1120 eligible Non-VAP patients. Additionally, VAP patients will be recruited such that between 25% and 30% of the total number of patients recruited are VAP in nature. So a minimum total of 1494 patients (1120 Non-VAP plus 374 VAP) and a maximum total of 1600 patients (1120 Non-VAP plus 480 VAP) with NP including VAP will be recruited into this study from approximately 22 countries. From India, a total of 100 patients will be randomised from approximately 12 sites. The recruitment in India is expected to start from May 2014.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ 18 to 90 years of age inclusive.
- •â€¢ Females can participate if surgically sterile or completed menopause; if able to have children, must have negative serum pregnancy test, agree not to attempt pregnancy and use acceptable contraception while receiving study therapy and for 1 week after last dose of IV study therapy.
- •â€¢ Onset of symptoms more than or equal to 48 hours after admission or less than 7 days after discharge from an inpatient acute or chronic care facility.
- •â€¢ New or worsening infiltrate on chest X-ray obtained within 48 hours prior to randomization.
- •â€¢ At least 1 of the following systemic signs: Fever (temperature more than 38 degree C) or hypothermia (rectal/core temperature less than 35 degree C); White blood cell count more than10,000 cells/mm3, or White blood cell count less than 4500 cells/mm3, or more than15% band forms.
排除标准
- •â€¢ Pulmonary disease that precludes evaluation of therapeutic response (including, but not limited to, lung cancer, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection or recent pulmonary embolism).
- •â€¢ Patients with lung abscess, pleural empyema or post obstructive pneumonia.
- •â€¢ Patients with an estimated creatinine clearance 16ml/min by Cockcroft Gault formula or patients expected to require haemodialysis or other renal support while on study therapy.
- •â€¢ Acute hepatitis in the prior 6 months, cirrhosis, acute hepatic failure or acute decompensation of chronic hepatic failure.
- •â€¢ Patients receiving hemodialysis or peritoneal dialysis.
结局指标
主要结局
The proportion of patients with clinical cure in the clinically modified intent-to-treat and clinically evaluable analysis sets (co-primary analyses)
时间窗: Up to 25 days from randomization | 21st - 25th day from randomization
次要结局
- Proportion of patients with a favorable per-patient microbiologic response in patients with pathogens resistant to ceftazidime in microbiologically modified intent-to-treat, microbiologically evaluable, extended microbiologically evaluable analysis sets(up to 14 days from randomization and 21 to 25 from randomization)
- The proportion of favorable per-pathogen microbiologic responses in patients with pathogens resistant to ceftazidime in microbiologically modified intent-to-treat, microbiologically evaluable and extended microbiologically evaluable analysis sets(up to 14 days from randomization and 21 to 25 from randomization)
- The proportion of patients with death due to any cause (all-cause mortality) in the clinically evaluable, clinically modified intent-to-treat and microbiologically modified intent-to-treat analysis sets(at Day 21 to 25 from randomization and Day 28 from randomization)
- The proportion of patients discharged from hospital in the clinically evaluable, clinically modified intent-to-treat and microbiologically modified intent-to-treat analysis sets(up to 25 days from randomization)
- The proportion of patients with clinical cure in clinically modified intent-to-treat, clinically evaluable, microbiologically modified intent-to-treat, microbiologically evaluable, extended microbiologically evaluable analysis sets(up to 14 days from randomization)
- The proportion of patients with clinical cure in the microbiologically modified intent-to-treat, microbiologically evaluable and extended Microbiologically evaluable analysis sets(Up to 25 days from randomization)
- The proportion of patients with a favorable per-patient microbiologic response in microbiologically modified intent-to-treat, microbiologically evaluable, extended microbiologically evaluable analysis sets(up to 14 days from randomization and 21 to 25 from randomization)
- The proportion of favorable per-pathogen microbiologic responses in microbiologically modified intent-to-treat, microbiologically evaluable and extended microbiologically evaluable analysis sets(up to 14 days from randomization and 21 to 25 from randomization)
- The proportion of favorable per-pathogen microbiologic responses by minimum inhibitory concentration categories in microbiologically modified intent-to-treat, microbiologically evaluable and extended-microbiologically evaluable analysis sets(up to 14 days from randomization and 21 to 25 from randomization)
- The proportion of patients with clinical cure in patients with pathogens resistant to ceftazidime in clinically evaluable, clinically modified intent-to-treat, microbiologically evaluable analysis sets(up to 14 days from randomization and 21 to 25 from randomization)
- Safety and tolerability by incidence and severity of adverse events and serious adverse events, mortality, reasons for discontinuations of study therapy, vital signs, physical exams, electrocardiogram parameters, and clinical laboratory tests(up to 28 days from randomization)
研究者
研究点 (9)
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