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.

BKRS PHARMA PVT LTD0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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)

•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 16Âµg/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

发起方

BKRS PHARMA PVT LTD