A Clinical study to evaluate the Efficacy and Safety of drug IZIPENEM (Meropenem 1000 mg/ml injection) in patients with Bacterial infections.

Phase 3

Completed

Conditions: Bacterial Infections: Respiratory tract infections, Urinary tract infections , gynaecological Infections and Bacterial meningitis

Brief Summary: **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.**

Recruitment & Eligibility

Inclusion Criteria

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).

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
Changes in Clinical Evaluation of bacterial infections	screening to End of Treatment ( Day-4

Secondary Outcome Measures

Name	Time	Method
Changes in the microbial response levels	Incidence and rate of adverse events

Locations (1): Sri Venkateshwara Hospital
🇮🇳
Bangalore, KARNATAKA, India
Sri Venkateshwara Hospital
🇮🇳Bangalore, KARNATAKA, India
Dr N Vijaya Kumar
Principal investigator
9448116114
kumardrvijay5@gmail.com