Status:
COMPLETED
A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia
Lead Sponsor:
Pfizer
Conditions:
Nosocomial Pneumonia (NP)
Ventilator-associated Pneumonia (VAP)
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia
Detailed Description
A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the T...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Pulmonary disease that, in the investigator's judgment, would preclude evaluation of therapeutic response (e.g. 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
969 Patients enrolled
Trial Details
Trial ID
NCT01808092
Start Date
April 1 2013
End Date
January 1 2016
Last Update
September 6 2017
Active Locations (123)
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1
Research Site
Buenos Aires, Argentina
2
Research Site
Córdoba, Argentina
3
Research Site
Florida, Argentina
4
Research Site
La Plata, Argentina