A clinical trial to study the safety, efficacy and tolerability of the drug Ceftazidime-Avibactam(CAZ-AVI) versus Meropenem in patients with Nosocomial Pneumonia(NP) including Ventilator Associated Pneumonia(VAP).
- Conditions
- Health Condition 1: null- Nosocomial Pneumonia (NP)Ventilator Associated Pneumonia (VAP)Health Condition 2: J189- Pneumonia, unspecified organism
- Registration Number
- CTRI/2014/05/004622
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
• 18 to 90 years of age inclusive.
• Females can participate if surgically sterile or completed menopause; if able to have children, must have negative serum pregnancy test, agree not to attempt pregnancy and use acceptable contraception while receiving study therapy and for 1 week after last dose of IV study therapy.
• Onset of symptoms more than or equal to 48 hours after admission or less than 7 days after discharge from an inpatient acute or chronic care facility.
• New or worsening infiltrate on chest X-ray obtained within 48 hours prior to randomization.
• At least 1 of the following systemic signs: Fever (temperature more than 38 degree C) or hypothermia (rectal/core temperature less than 35 degree C); White blood cell count more than10,000 cells/mm3, or White blood cell count less than 4500 cells/mm3, or more than15% band forms.
• Pulmonary disease that precludes evaluation of therapeutic response (including, but not limited to, lung cancer, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection or recent pulmonary embolism).
• Patients with lung abscess, pleural empyema or post obstructive pneumonia.
• Patients with an estimated creatinine clearance 16ml/min by Cockcroft Gault formula or patients expected to require haemodialysis or other renal support while on study therapy.
• Acute hepatitis in the prior 6 months, cirrhosis, acute hepatic failure or acute decompensation of chronic hepatic failure.
• Patients receiving hemodialysis or peritoneal dialysis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method