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 Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults

CompletadoFase 3ClinicalTrials.gov

ID: NCT01808092Tipo: INTERVENTIONALInicio: 1 de abr de 2013Fin estimado: 1 de ene de 2016

Traducción no disponible, mostrando original

Resumen

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

Descripción detallada

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 Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 90 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

ceftazidim-avibactam (CAZ-AVI, experimental product)

2000mg ceftazidime plus 500mg avibactam

drug

meropenem (active comparator)

1000mg of Meropenem

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Córdoba, Argentina

Research Site

Florida, Argentina

Research Site

La Plata, Argentina

Research Site

Mendoza, Argentina

Patrocinadores

PrincipalPfizer

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