Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia
Condition: Community Acquired Bacterial Pneumonia
MeSH terms: Pneumonia; Pneumonia, Bacterial
Intervention: Delafloxacin; Moxifloxacin; Linezolid
Intervention description: Antibacterial agent, 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total; Antibacterial Agent, 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total; Antibacterial Agent, at local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses
Intervention MeSH terms: Moxifloxacin; Linezolid; Delafloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 860.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pneumonia

Summary:

      The purpose of this study is to evaluate the safety and efficacy of delafloxacin compared to
      moxifloxacin in the treatment of adult patients with community-acquired pneumonia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female 18 years of age or older

          2. Evidence of acute onset of CABP with 2 or more of the following symptoms (new or
             worsening)

               -  Cough

               -  Production of purulent sputum consistent with bacterial infection

               -  Difficulty breathing

               -  Chest pain due to pneumonia

             AND have at least 2 of the following findings:

               -  Fever (oral temperature >38.0°C)

               -  Hypothermia (oral temperature <35.0°C)

               -  Tachycardia (heart rate >100 beats/min)

               -  Tachypnea (respiratory rate >18 breaths/min)

             AND have at least 1 of the following findings:

               -  Hypoxemia (oxygen saturation <90% or PaO2 < 60 mmHg) on room air or with
                  subject's baseline (pre-CABP under study) supplemental oxygen

               -  Clinical evidence of pulmonary consolidation and/or presence of pulmonary rales

               -  An elevated white blood cell count (WBC) >10,000/mm3 or 15% immature neutrophils
                  (bands), regardless of total peripheral WBC count or leukopenia with WBC
                  <4500/mm^3

          3. Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with
             acute bacterial pneumonia on a pulmonary imaging study within 48 hours before the
             first dose of study drug

          4. PORT risk class of II to V (PSI score >50)

          5. Must be a suitable candidate for possible IV to oral switch antibiotic therapy and
             must also be able to swallow large tablets/capsules intact without crushing

        Exclusion Criteria:

          1. A medical history of significant hypersensitivity or allergic reaction to antibiotics
             of the quinolone or oxazolidinone class or study drug excipients according to the
             investigator

          2. Any infection expected to require other systemic antibiotics in addition to study drug

          3. Receipt of systemic antibiotic therapy in the 7 days before enrollment unless 1 of the
             following is documented:

               -  Received at least 48 hours of antibiotic therapy for CABP and clinic notes
                  document treatment failure (i.e., not by patient history or pulmonary imaging
                  alone) with new or worsening symptoms while on pre-study therapy

               -  Received 1 dose of a single, potentially effective, short-acting antibacterial
                  drug or drug regimen for CABP within 24 hours before enrollment (limited to 25%
                  of enrolled patients)

          4. Respiratory infection confirmed or suspected to be secondary to hospital-acquired or
             ventilator-associated pneumonia OR requires treatment in an intensive care setting, OR
             requires mechanical ventilation

          5. Current or suspected diagnosis of viral, fungal, or aspiration pneumonia,
             noninfectious causes of pulmonary infiltrates, lung cancer, cystic fibrosis,
             tuberculosis, empyema (not including sterile parapneumonic effusions)

          6. Known anatomical or pathological bronchial obstruction OR history of bronchiectasis OR
             GOLD Stage 4 COPD OR history of post obstructive pneumonia

          7. Severely compromised immune system

          8. Known history of Child-Pugh Class B or C liver disease

          9. History of post-antibiotic colitis within last 3 months

         10. Other exclusions include those described in the safety label for drugs in the
             quinolone and/or oxazolidinone classes such as QT prolongation, proarrhythmic
             conditions, concomitant use of drugs known to cause QT prolongation, peripheral
             neuropathy, tendon disorders, history of myasthenia gravis, liver disease, severe
             renal disease, seizures and concomitant use of MAO A or B inhibitor agents and
             adrenergic serotonergic agents