NCT01371838已完成3 期
A Phase III, Multicentre, Randomised, Double-Blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia
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
- 848
- 试验地点
- 1
- 主要终点
- Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population
研究概览
简要总结
This purpose of this study is to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 150 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females 18 or more years of age
- •Lung Infection of Individual not Recently Hospitalized meeting the following criteria: Radiographically-confirmed pneumonia (new or progressive infection site of the lungs) consistent with bacterial pneumonia), AND Acute illness (≤ 7 days duration) with at least three of the following clinical signs or symptoms consistent with lung infection: New or increased cough, Purulent sputum or change in sputum character, Auscultatory findings consistent with pneumonia, Difficulty in breathing, short breath, or decreased partial pressure of oxygen in blood, Fever greater than 38ºC oral or body temperature lower than that required for normal body function(< 35ºC), White blood cell count greater than or less than the normal, Greater than 15% immature neutrophils (bands) irrespective of white blood cell count, AND Moderate lung infection
- •The subject must require initial hospitalization, or treatment in an emergency room or urgent care setting, by the standard of care
- •The subject's infection would require initial treatment with intravenous antimicrobials
- •Female subjects of child-bearing potential, and those who are fewer than 2 years post-menopausal, must agree to, and comply with, using highly effective methods of birth control while participating in this study
排除标准
- •Lung Infection of Individual not Recently Hospitalized suitable for outpatient therapy with an oral antimicrobial agent
- •Confirmed or suspected respiratory tract infections attributable to sources other than bacteria from the individuals not recently hospitalized(e.g., ventilator-associated pneumonia, hospital-acquired pneumonia, visible/gross aspiration pneumonia, suspected viral, fungal, or mycobacterial infection of the lung)
- •Non-infectious causes of lung lesion (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
- •Accumulation of pus in the pleural cavity
- •Microbiologically-documented infection with a pathogen known to be resistant to ceftriaxone, or epidemiological or clinical context suggesting high likelihood of a ceftriaxone-resistant "typical" bacterial pathogen.
研究组 & 干预措施
Ceftaroline
Experimental
干预措施: Ceftaroline (Drug)
Ceftriaxone plus placebo
Active Comparator
干预措施: Ceftriaxone (Drug)
结局指标
主要结局
Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population
时间窗: 7-20 days after last dose of study drug
Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: •Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy •Treatment-limiting AE leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia •Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome
次要结局
- Clinical Response at End of Treatment (EOT) Visit in MITT Population(Last day of study drug administration)
- Clinical Response at End of Treatment (EOT) Visit in CE Population(Last day of study drug administration)
- Clinical Response at the Test of Cure (TOC) Visit in MITT Population(7-20 days after last day of study drug administration)
- Clinical Response at the Test of Cure (TOC) Visit in mMITT Population(7-20 days after last day of study drug administration)
- Clinical Response at the Test of Cure (TOC) Visit in ME Population(7-20 days after last day of study drug administration)
- Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population(7-20 days after last dose of study drug)
- Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in MITT Population(21-42 days after last day of study drug administration)
- Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population(21-42 days after last dose of study drug)
- Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population(7-20 days after last dose of study drug)
- Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population(7-20 days after last day of study drug administration)
- Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in MITT Population(7-20 days after last day of study drug administration)
- Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in CE Population(7-20 days after last dose of study drug)
- Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population(7-20 days after last day of study drug administration)
- Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in CE Population(21-42 days after last day of study drug administration)
- Microbiological Re-infection/Recurrence at LFU Visit in ME Population(21-42 days after last dose of study drug)
研究者
研究点 (1)
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