Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia
Condition: Community Acquired Pneumonia
MeSH terms: Pneumonia
Intervention: lefamulin; Moxifloxacin
Intervention description: antibacterial agent; antibacterial agent
Intervention MeSH terms: Moxifloxacin; 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: 738.0
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 community-acquired bacterial pneumonia
    

Eligibility criteria:

        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).