Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia

Inclusion Criteria

• •1. Be male or female at least 18 years of age.
• •2. Provide written informed consent and be willing and able to adhere to the study-specified procedures and restrictions.
• •3. Have an acute illness (7 days duration) with at least 3 of the following symptoms consistent with a lower respiratory tract infection (new or worsening):
• •* Dyspnea
• •* New or increased cough
• •* Purulent sputum production
• •* Chest pain due to pneumonia
• •4. Have at least 2 of the following vital sign abnormalities:
• •* Fever (body temperature \>38.0°C (100.4°F) measured orally or equivalent temperature from an alternate body site) or hypothermia (body temperature \<35.0°C (95.0°F) measured orally or equivalent temperature from an alternate body site)
• •* Hypotension (systolic blood pressure \<90 mmHg)
• •* Tachycardia (heart rate \>100 beats/min)
• •* Tachypnea (respiratory rate \>20 breaths/min)
• •5. Have at least 1 other clinical sign or laboratory finding of CABP:
• •* Hypoxemia (i.e., O2 saturation \<90% on room air or while receiving supplemental oxygen at subject's baseline requirement or PaO2 \<60 mmHg)
• •* Auscultatory and/or percussion findings consistent with pneumonia (e.g., crackles, egophony, dullness)
• •* White blood cell (WBC) count \>10,000 cells/mm3 or \<4500 cells/mm3 or \>15% immature neutrophils (bands) regardless of total WBC count
• •6. Have radiographically-documented pneumonia within 48 hours before enrollment (i.e., infiltrates in a lobar or multilobar distribution or diffuse opacities on chest x-ray or chest computed tomography scan consistent with acute bacterial pneumonia).
• •7. Have a Pneumonia Outcomes Research Team (PORT) Risk Class ≥III.