A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone, With Adjunctive Clarithromycin, in the Treatment of Adult Subjects With Community-Acquired Pneumonia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 606
- 试验地点
- 7
- 主要终点
- Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population
研究概览
简要总结
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia
详细描述
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia. Clinical trials for this study is held in many countries
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects are required to meet the following inclusion criteria:
- •Community-acquired pneumonia
- •initial hospitalization, or treatment in an emergency room or urgent care setting
- •infection would require initial treatment with IV antimicrobials.
排除标准
- •Subjects must NOT meet any of the following exclusion criteria:
- •CAP suitable for outpatient therapy with an oral antimicrobial agent
- •respiratory tract infections not due to community-acquired bacterial
- •Non-infectious causes of pulmonary infiltrates
- •Pleural empyema
- •Infection with an atypical organism
- •History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial
- •History of any hypersensitivity or allergic reaction to clarithromycin or any macrolide/ ketolide
研究组 & 干预措施
Ceftaroline fosamil for Injection
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h).
In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
干预措施: Ceftaroline fosamil for Injection (Drug)
Ceftaroline fosamil for Injection
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h).
In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
干预措施: Clarithromycin (Drug)
IV Ceftriaxone
Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
干预措施: IV Ceftriaxone (Drug)
IV Ceftriaxone
Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
干预措施: Placebo (Drug)
IV Ceftriaxone
Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
干预措施: Clarithromycin (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 the Clinically Evaluable (CE) Population
时间窗: 8-15 days after last dose of study drug
Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations
时间窗: 8 to 15 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 adverse event (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
- Microbiological Success Rate at Test of Cure (TOC)(8-15 days after last dose of study drug)
- Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC)(8-15 days after last day of study drug)
- Clinical Response at End of Therapy (EOT)(Last day of study drug administration)
- Evaluate Safety(first dose, throughout the treatment period, and up to the TOC visit)
- Clinical and Microbiological Response by Pathogen at TOC(8-15 days after last dose of study drug)
- Clinical Relapse at Late Follow Up (LFU)(21-35 days after last dose of study drug)
- Microbiological Re-infection/Recurrence at LFU(21 to 35 days after last dose of study drug)