Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia (SOLITAIRE-ORAL)

This is an interventional treatment trial for Community-acquired Bacterial Pneumonia focused on measuring Pneumonia, CABP, CAP, Macrolide Read More

Inclusion Criteria:

• Male and female patients ≥ 18 years of age

• An acute onset of at least 3 of the following signs and symptoms (new or worsening):

  1. Cough
  2. Production of purulent sputum
  3. Shortness of breath (dyspnea)
  4. Chest pain due to pneumonia

• At least 1 of the following:

  1. Fever
  2. Hypothermia
  3. Presence of pulmonary rales and/or evidence of pulmonary consolidation
• PORT Risk Class II, III, or IV
• Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study
• Not received any systemic antibiotics during the prior 7 days

Exclusion Criteria:

• Ventilator-associated pneumonia
• Known anatomical or pathological bronchial obstruction or a history of bronchiectasis or documented severe chronic obstructive pulmonary disease
• Hospitalization within 90 days or residence in a long-term care facility within 30 days prior to the onset of symptoms

• Presence of known:

  1. Viral or fungal pneumonia
  2. Pneumocystis jiroveci pneumonia
  3. Aspiration pneumonia
  4. Other non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism, hypersensitivity pneumonia, congestive heart failure)
  5. Primary or metastatic lung cancer
  6. Cystic fibrosis
  7. Active or suspected tuberculosis
• Known HIV or myasthesia gravis