Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia
Condition: Community Acquired Pneumonia
MeSH terms: Pneumonia
Intervention: lefamulin; Moxifloxacin; Linezolid
Intervention description: antibacterial agent; antibacterial agent; antibacterial agent
Intervention MeSH terms: Moxifloxacin; Linezolid; Lefamulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 551.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pneumonia; CABP; CAP; Community acquired bacterial pneumonia

Summary:

      This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment
      of adults with moderate to severe community-acquired bacterial pneumonia.
    

Eligibility criteria:

        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.

        Exclusion Criteria:

          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., 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).

          7. Require mechanical ventilation.