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A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia

Last updated on March 14, 2019

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Study Location
Research Site
Buenos Aires, , Argentina
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nosocomial Pneumonia (NP), Ventilator-associated Pneumonia (VAP)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-90 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 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 10,000 cells/mm3, or White
blood cell count 15% band forms.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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 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.

NCT01808092
Pfizer
Completed
A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia

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