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 thestudy-specified procedures and restrictions.

3. Have an acute illness (7 days duration) with at least 3 of the following symptomsconsistent 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 equivalenttemperature 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 supplementaloxygen 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-rayor chest computed tomography scan consistent with acute bacterial pneumonia).

7. Have a Pneumonia Outcomes Research Team (PORT) Risk Class ≥III.

Exclusion Criteria:

1. Have received more than a single dose of a short-acting oral or IV antibacterial forCABP within 72 hours before randomization

2. Require concomitant systemic antibacterial therapy potentially effective against CABPpathogens

3. Have been hospitalized for 2 or more days within 90 days prior to the onset ofsymptoms or have resided in a nursing home or long-term healthcare facility within 30days prior to the onset of symptoms. NOTE: Residence in an independent living facilityis permitted.

4. Have confirmed or suspected CABP caused by a pathogen known to be resistant to any ofthe study drugs (e.g., Pseudomonas aeruginosa, any pathogen of the EnterobacteriaceaeFamily) or attributable to etiologies other than community acquired bacterialpathogens (e.g., ventilator associated pneumonia, hospital acquired bacterialpneumonia, bacterial aspiration pneumonia, Pneumocystis jiroveci pneumonia or otherfungal pneumonia, viral or mycobacterial infection of the lung).

5. Have a noninfectious cause of pulmonary infiltrates (e.g., pulmonary embolism,chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heartfailure, bronchial obstruction, lung cancer, cystic fibrosis).

6. Have confirmed or suspected pleural empyema (does not include sterile parapneumoniceffusions).

7. Require mechanical ventilation.