A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia

Inclusion Criteria:

• Males and non-pregnant, non-lactating females, 20 years of age or older. Women of childbearing potential and men must agree to use adequate contraception when sexually active.
• Within 48 hours prior to the first study drug administration, all patients should have the pathogens identified with appropriate specimens (e.g., sputum, tracheal aspirate, bronchoalveolar lavage [BAL], protected brushing specimen [PBS]), or should have appropriate specimens highly likely to identify the pathogens sampled.

• The following severe bacterial pneumonia meeting the diagnostic criteria of pneumonia

  • Community acquired pneumonia: PORT score III, IV or V#,
  • Hospital acquired pneumonia [HAP]-Group B* and with a low risk for multidrug-resistant pathogens
  • Patient with HAP-Group A* whose pathogen is suspected to be Pseudomonas aeruginosa
  • Hospitalized patients with bacterial pneumonia with a poor response to other antimicrobials Note: The patients should be limited to CAP patients with PORT score III, IV or V and HAP patients with Group A or B who don't respond to or have a poor response to other antimicrobials over 3 day's treatment.

Exclusion Criteria:

• Creatinine clearance (Ccr) < 60 mL/min or nephrotic syndrome
• Patient with chronic treatment of immunosuppressive drug
• Decompensated congestive heart failure
• Subject who received more than 24 hours of an antibacterial drug for the current infection
• Patient who requires Intensive Care Unit (ICU) management [In case subjects who don't correspond to the severity for ICU management need to be admitted to ICU due to a circumstance of the site (e.g. shortage of hospital beds), those subjects shall not be excluded]
• Patients with infections other than pneumonia
• Primary, solitary lung abscess, or empyema
• Viral, fungal, mycobacterial, or atypical pneumonia as a primary diagnosis
• Known or suspected bacteremia secondary to Staphylococcus aureus
• Known causative microorganisms other than indication (microorganisms) of the study drug, or positive in urinary antigen test of Streptococcus pneumonia
• Infection that necessitates the use of a concomitant antibacterial agent in addition to study medication
• Known bronchial obstruction or a history of post-obstructive pneumonia
• Known primary lung cancer