A Prospective, Interventional, Randomised, Double Blind, Parallel Group, Comparative Clinical study to evaluate the Efficacy and Safety of drug IZIPENEM (Meropenem 1000 mg/ml injection) and reference drug Meronem IV in patients with Bacterial infections.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in Clinical Evaluation of bacterial infections
研究概览
简要总结
A Prospective ,Interventional, Randomised, Double Blind ,Parallel Group Comparative clinical study to evaluate the efficacy and safety of drug IZIPENEM (Meropenem 1000 mg/ml injection) and reference drug Meronem IV in patients with bacterial infections Purpose of the study : To compare the safety and Efficacy of drug IZIPENEM (Meropenem 1000 mg /ml injection) and reference drug Meronem IV in patients with bacterial infections. A total of 60 subjects would be enrolled for the study for 14 days. The data will be analyzed for non - inferiority with 5 % significance level and 80% power for study using SAS. The difference within the group will be assessed using paired T -Test. The difference between the groups will be assessed using independent T-Test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female above 18 years with respiratory tract infection,urinary tract infection ,gynaecological infections, bacterial Meningitis ( any one of the disease).
- •Patients should have clinical findings that support a diagnosis of HABP/VABP/HCAP Within 48 hours before starting empiric therapy a subject chest radiograph should show the presence of a New or progressive infiltrate, cavitation, or effusion suggestive of pneumonia Patients with VABP should have a clinical pulmonary infection score greater than or equal to 5 Lower Urinary tract infection symptoms(dysuria, urgency, frequency, suprapubic pain).
排除标准
- •Metastatic hepatic disease Malignant ascites CNS disease, including metastatic CNS disease Cirrhosis, Adult respiratory distress syndrome Marked hepatic disease (bilirubin level, more than twice the upper limit of normal [ULN] or alanine aminotransferase level, more than four times the ULN) Known or suspected significant renal impairment (serum creatinine level, greater than 1.5 mg/dL) Neurosurgery within 1 month of entry into the trial Conditions treated with anticonvulsant medications Active colitis Exposure to other investigational drugs within days of trial entry Neutropenia History of Cystic fibrosis, polycystic Kidney Disease, cervical cancer, Poly microbial bacteremia.
- •Auto-immune disease, lymphoma or leukemia Subjects with pneumonia caused by pathogens resistant to Meropenem (MIC greater than or equal to 16µg/ml) or a prior meropenem therapy failure.
- •In case of renal abscess, lack of early drainage Haematogenous infection or other concomitant infection Renal transplant recipients Partial or complete cervical excision Auto-immune disease Bacterial Vaginosis or Candidiasis (current or past 3 months) History of allergies to Beta-lactam antimicrobials.
结局指标
主要结局
Changes in Clinical Evaluation of bacterial infections
时间窗: screening to End of Treatment ( Day-4
次要结局
- Changes in the microbial response levels(Incidence and rate of adverse events)