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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Nosocomial Pneumonia (NP); Ventilator-associated Pneumonia (VAP)

Treatments: Drug: ceftazidim-avibactam (CAZ-AVI, experimental product); Drug: meropenem (active comparator)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01808092

D4281C00001

Details and patient eligibility

About

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

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

Enrollment: 969 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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969 participants in 2 patient groups

CAZ-AVI

Experimental group

Description:

Intra-Venous treatment

Treatment:

Drug: ceftazidim-avibactam (CAZ-AVI, experimental product)

Meropenem

Active Comparator group

Description:

Intra-Venous treatment

Treatment:

Drug: meropenem (active comparator)