Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia
Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia
This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment
 of adults with moderate community-acquired bacterial pneumonia
Lefamulin is a potent, semi-synthetic antibacterial belonging to a novel class known as the
 pleuromutilins. The oral dosage form of lefamulin is under investigation in this study.
 Lefamulin's in vitro antibacterial profile includes the most important bacterial pathogens
 causing respiratory tract infection (RTI). The antibacterial spectrum comprises S.
 pneumoniae, H. influenzae, M. catarrhalis, the atypical respiratory pathogens L. pneumophila,
 C. pneumoniae, and M. pneumoniae, S. aureus including MRSA and CA-MRSA, ß-haemolytic
 streptococci including S. pyogenes and S. agalactiae, and Enterococcus faecium including
 vancomycin-resistant enterococci (VRE). Moreover, as demonstrated in cross-resistance
 studies, lefamulin remains active against clinical isolates resistant to the following
 antimicrobial(s) (classes): macrolides, lincosamides, streptogramin B, oxazolidinones,
 tetracyclines, ß lactams, quinolones, trimethoprim-sulfametoxazole, mupirocin, and
 vancomycin.
Inclusion Criteria:

 Each subject must:

 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 (less than or equal to 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 < 4 500 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 of II, III, or IV and be an
 appropriate candidate for oral antibiotic therapy as treatment for the current episode
 of CABP.

 Exclusion Criteria:

 Each subject must NOT:

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

 2. Require concomitant systemic antibacterial therapy potentially effective against CABP
 pathogens.

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

 4. Have confirmed or suspected CABP caused by a pathogen known to be resistant to any of
 the study drugs (e.g., MRSA, Pseudomonas aeruginosa, any pathogen of the
 Enterobacteriaceae Family) or attributable to etiologies other than community acquired
 bacterial pathogens (e.g., ventilator associated pneumonia, hospital acquired
 bacterial pneumonia, bacterial aspiration pneumonia, Pneumocystis jiroveci pneumonia
 or other fungal 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 heart
 failure, bronchial obstruction, lung cancer, cystic fibrosis).

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