A Clinical study to evaluate the Efficacy and Safety of drug IZIPENEM (Meropenem 1000 mg/ml injection) in patients with Bacterial infections.
- Conditions
- Health Condition 1: - Health Condition 2: null- Bacterial Infections: Respiratory tract infections, Urinary tract infections , gynaecological Infections and Bacterial meningitis
- Registration Number
- CTRI/2017/11/010369
- Lead Sponsor
- BKRS PHARMA PVT LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in Clinical Evaluation of bacterial infectionsTimepoint: screening to End of Treatment ( Day-4
- Secondary Outcome Measures
Name Time Method Changes in the microbial response levels <br/ ><br>Incidence and rate of adverse events <br/ ><br>Timepoint: Screening to End of Treatment ( Day 4)