A Post Marketing Surveillance Study on the Safety and Effectiveness of Doripenem in the Therapy of Thai Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 主要终点
- Number of Participants With Adverse Events (AEs) and Number of Participants Discontinued Because of AEs
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of doripenem in participants with nosocomial pneumonia (inflammation of the lungs in which the lungs become heavy; pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal (in belly) infections and complicated urinary tract infections (bladder infections).
详细描述
This is an open-label (all people involved know the identity of the intervention), multi-center (conducted in more than 1 center) study, to evaluate the safety and effectiveness of doripenem in treating Thai participants with nosocomial pneumonia, complicated intra-abdominal and urinary tract infections. The study consists of 4 visits: Visit 1 (Baseline), Visit 2 (End-of-Treatment [EOT], up to Day 14), Visit 3 (Phone visit, Test-of-Cure [TOC], up to Day 14 after EOT) and Visit 4 (Phone visit, Day 90). Participants will receive 500 milligram (mg) of doripenem as intravenous infusion (directly into the vein) every 8 hours for at least 3 days after clinical response and extended up to 14 days. Efficacy will primarily be evaluated by determination of clinical response. Participants' safety will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants with 18 years old age and above
- •Diagnosed nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections
- •Must have evidence of a systemic inflammatory response syndrome with at least one of the these: fever (body temperature greater than 38 degree celcius) or hypothermia (body temperature less than 36 degree celcius) or elevated total peripheral white blood cell count greater than or equal to 12,000 cells per cubic millimeter or leukopenia with less than 4,000 cells per cubic millimeter or decrease in blood pressure relative to Baseline of greater than 15 millimeter of mercury systolic or increased pulse greater than 100 beats per minute (bpm) and respiratory rates greater than 20 bpm
- •Candidate for treatment with carbapenems, with at least one of these conditions: Empirical therapy; suspected infection caused by carbapenem susceptible P. aeruginosa or carbapenem-susceptible A. baumannii or MDR gram negative bacteria or nosocomial infection with failure of previous treatment or modified therapy; known pathogens with resistance to cephalosporins,aminoglycosides, fluoroquinolones or beta-lactam/ batalactamase intibitor and susceptible to carbapenem or known infection caused by gram negative bacteria
- •Signed informed consent
排除标准
- •Pregnant or lactating female participants
- •History of severe allergies to antibiotics such as penicillins, cephalosporins and carbapenems
- •Hypersensitivity to doripenem and/or excipients
- •Previous use of carbapenems within 7 days of study entry
- •Participants in terminal stage of malignancy
研究组 & 干预措施
Nosocomial Pneumonia
Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
干预措施: Doripenem (Drug)
Complicated Intra-Abdominal Infections
Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
干预措施: Doripenem (Drug)
Complicated Urinary Tract Infections
Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
干预措施: Doripenem (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Number of Participants Discontinued Because of AEs
时间窗: Up to 30 days after last dose of study drug
An adverse event is any untoward medical occurrence in a participant administered with a pharmaceutical product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The number of participants discontinued because of AEs were also reported.
次要结局
- Percentage of Participants With Clinical Response at Test-of-Cure (TOC)(Up to Day 14 after End-of-Treatment (EOT))
- Percentage of Participants With Clinical Response at End-of-Treatment (EOT)(Up to Day 14 (EOT))
- Number of Participants With 90-day Mortality(up to Day 90)