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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

Last updated on March 14, 2019

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Study Location
Research Site
Beijing, , China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Community-Acquired Bacterial Pneumonia, Lung Infection of Individual Not Recently Hospitalized
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-150 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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( 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT01371838
Pfizer
Completed
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

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[email protected]

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