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
Condition: Community-Acquired Bacterial Pneumonia; Lung Infection of Individual Not Recently Hospitalized
MeSH terms: Pneumonia; Pneumonia, Bacterial
Intervention: Ceftaroline; Ceftriaxone
Intervention description: Two consecutive infusions q12h for 5 to 7 days; One dose infusion followed by IV saline placebo infused q24h for 5 to 7 days plus two consecutive saline placebo infusion q24h.
Intervention MeSH terms: Ceftriaxone; Ceftaroline fosamil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 848.0
Sex: All
Minimum age: 18 Years
Maximum age: 150 Years
Healthy volunteers: No
Keywords: Community-Acquired Bacterial Pneumonia

Summary:

      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.
    

Eligibility criteria:

        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.