CTRI/2013/02/003401已完成3 期
A Phase III, Multicenter, Randomized, Open Label, Clinical study To evaluate Efficacy and Safety of two strengths of Meropenem Plus Tazobactam For the Treatment of Patients with Gram Negative Infection Including Pseudomonas aeruginosa
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- Overall Clinical Response
研究概览
简要总结
This will be a multicentric, open-label, randomised, phase III clinical trial involving patients with gram negative infection including Pseudomonas aeruginosareceiving FDC meropenem 1 gm + tazobactam 125mg/250mg injection (Investigationa product) or meropenem 1 gm injection (comparator product) three times in a day for 7-14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Written informed consent from the patient.
- •2.Male or Female patients aged greater than or equals to 18 years.
- •3.Patient’s culture defining presence of gram negative infection including Pseudomonas aeruginosa.
- •4.Patients who failed to prior antibacterial treatment can be enrolled but must have a positive culture test.
- •5.Willingness to comply with the study schedule and procedures.
排除标准
- •1.Patients with any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
- •2.Baseline pathogens known to be resistant to study agents at the study entry.
- •3.Concurrent confounding infection.
- •4.Patients who consume alcohol should not be enrolling into the study.
- •5.History of anaphylaxis or serious allergy to either study agent or antibiotic agents in the β-lactam class.
- •6.Patients having low likelihood of either treatment response or survival to follow-up visit.
- •7.Patients with ALT or AST more than six times the upper limit of normal (ULN).
- •8.Patients with neutropenia ( 1000 x million neutrophils/L).
- •9.A history of significant underlying disease or of hypersensitivity to either of the trial drugs.
- •10.Patient is a female who is pregnant or willing to get pregnant, no ready to use contraceptive measures during the trial period of breast feeding.
- •11.Hypovolaemia or dehydration from any cause.
- •12.Participation in any other clinical trial during last 30 days.
结局指标
主要结局
Overall Clinical Response
时间窗: 7-14 days
次要结局
- Changes in culture test for gram negative infection including Pseudomonas aeruginosa, Average Treatment Duration(7-14 days)
研究者
研究点 (8)
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