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

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
• Fungal pneumonia
• Pneumocystis jiroveci pneumonia
• Aspiration pneumonia
• Other non-infectious causes of pulmonary infiltrates
• Primary or metastatic lung cancer
• Cystic fibrosis
• Active or suspected tuberculosis
• HIV or myasthenia gravis