A Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia

Pfizer

Status and phase

Completed

Phase 3

Conditions

Lung Infection of Individual Not Recently Hospitalized

Community-Acquired Bacterial Pneumonia

Treatments

Drug: Ceftriaxone

Drug: Ceftaroline

Study type

Interventional

Funder types

Industry

Identifiers

NCT01371838

D3720C00002

Details and patient eligibility

About

This purpose of this study is to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia.

Enrollment

848 patients

Sex

All

Ages

18 to 150 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males and females 18 or more years of age
Lung Infection of Individual not Recently Hospitalized meeting the following criteria: Radiographically-confirmed pneumonia (new or progressive infection site of the lungs) consistent with bacterial pneumonia), AND Acute illness (≤ 7 days duration) with at least three of the following clinical signs or symptoms consistent with lung infection: New or increased cough, Purulent sputum or change in sputum character, Auscultatory findings consistent with pneumonia, Difficulty in breathing, short breath, or decreased partial pressure of oxygen in blood, Fever greater than 38ºC oral or body temperature lower than that required for normal body function(< 35ºC), White blood cell count greater than or less than the normal, Greater than 15% immature neutrophils (bands) irrespective of white blood cell count, AND Moderate lung infection
The subject must require initial hospitalization, or treatment in an emergency room or urgent care setting, by the standard of care
The subject's infection would require initial treatment with intravenous antimicrobials
Female subjects of child-bearing potential, and those who are fewer than 2 years post-menopausal, must agree to, and comply with, using highly effective methods of birth control while participating in this study

Exclusion criteria

Lung Infection of Individual not Recently Hospitalized suitable for outpatient therapy with an oral antimicrobial agent
Confirmed or suspected respiratory tract infections attributable to sources other than bacteria from the individuals not recently hospitalized(e.g., ventilator-associated pneumonia, hospital-acquired pneumonia, visible/gross aspiration pneumonia, suspected viral, fungal, or mycobacterial infection of the lung)
Non-infectious causes of lung lesion (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
Accumulation of pus in the pleural cavity
Microbiologically-documented infection with a pathogen known to be resistant to ceftriaxone, or epidemiological or clinical context suggesting high likelihood of a ceftriaxone-resistant "typical" bacterial pathogen.