A study comparing Ceftazidime-Avibactam versus Meropenem in hospitalized adults with nosocomial pneumonia
- Conditions
- nosocomial pneumonia (NP), ventilator-associated pneumonia (VAP)Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2012-004006-96-IT
- Lead Sponsor
- ASTRAZENECA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1494
• 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 • Onset of symptoms =48 hours after admission or <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 >38°C) or hypothermia (rectal/core temperature <35°C) - White blood cell count >10,000 cells/mm3, or White blood cell count<4500 cells/mm3, or >15% band forms
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 961
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 553
• 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the non-inferiority of ceftazidime-avibactam compared to meropenem with respect to clinical cure at the test of cure visit in patients in the clinically modified intent-to-treat population and patients in the clinically evaluable population;Secondary Objective: To determine the efficacy of CAZ-AVI compared to meropenem with respect to the clinical cure at end of treatment in the clinically modified intent-to-treat, clinically evaluable, microbiologically modified intent-totreat, microbiologically evaluable and extended microbiologically evaluable populations and at test of cure in the microbiologically modified intent-to-treat, microbiologically evaluable and extended microbiologically evaluable populations.;Primary end point(s): The proportion of patients with clinical cure in the clinically modified intent-to-treat and clinically evaluable analysis sets (co-primary analyses);Timepoint(s) of evaluation of this end point: at test of cure visit
- Secondary Outcome Measures
Name Time Method