A Phase 2 Study of Doripenem In The Treatment of Nosocomial and Ventilator-Associated Pneumonia In Hospitals
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 主要终点
- Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of doripenem monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia.
详细描述
Nosocomial pneumonia (NP) accounts for approximately 15% of all hospital-acquired infections. The incidence of NP rises in patients who are on breathing machines. The death rate for NP can be as high as 30%. NP caused by bacteria, such as Pseudomonas aeruginosa, has been associated with an increased death rate compared to other pathogens. Prompt use of appropriate antibiotics is essential. Compounding the issue of nosocomial infections is the increasing rate to which bacteria develop resistance to antibiotics. This hospital based trial is studying doripenem in patients who have nosocomial pneumonia to see if it is effective against bacteria associated with this serious bacterial infection. The duration of treatment can be anywhere from 8 to 14 days. Safety evaluations, such as vital signs and laboratory tests will be performed upon enrollment, after 4 days on therapy, after 9 days on therapy for those on greater than 8 days, at the end of therapy, 7 to 14 days after the end of therapy, and 28 to 35 days after the end of therapy. Adverse events will be collected throughout the study. Clinical response to doripenem therapy will be assessed 7 to 14 days after the end of therapy and the long-term clinical response to doripenem therapy will be assessed 28 to 35 days after the end of therapy. Doripenem IV will be administered for a duration of treatment from 8 to 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients suffering from Nosocomial Pneumonia or Ventilator-Associated Pneumonia
- •All patients must be hospitalized throughout the treatment period
- •Patients must have microbiological samples (respiratory secretions) suitable for culture and microscopy
排除标准
- •Known or suspected severe kidney impairment
- •Known or suspected liver dysfunction
- •Treatment with any investigational drug or device within 30 days before enrollment
- •Patients with one or more of the following: cystic fibrosis, lung abscess, active tuberculosis
- •Women who are pregnant or lactating
研究组 & 干预措施
Doripenem
1g i.v. infused over 4 hours every 8 hours for 8 to 14 days
干预措施: doripenem (Drug)
结局指标
主要结局
Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.
时间窗: 5 to 21 days after the last dose of study therapy, or at early termination.
The table below shows the percentage of subjects who had a clinical response of "clinical cure" at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of "clinical cure" is defined as no further antibacterial therapy needed for treatment of the infection.
次要结局
- Clinical Response Rates at the Late Follow-up Assessment.(28 to 35 days after last dose of study therapy)