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

Community-acquired bacterial pneumonia (CABP) is an acute infection of the pulmonary parenchyma with symptoms such as fever or hypothermia, chills, rigors, chest pain, and/or dyspnea. The widespread emergence of antibiotic resistant pathogens, including the macrolide-resistant Streptococcus pneumoniae, has resulted in a need for new and effective antibiotics that have activity against CABP pathogens. Solithromycin is a fourth generation macrolide antibiotic with excellent activity against resistant S. pneumoniae and other key typical and atypical bacterial respiratory pathogens. A completed Phase 2 study showed comparable efficacy to levofloxacin in adults with CABP.

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):

• Cough
• Production of purulent sputum
• Shortness of breath (dyspnea)
• Chest pain due to pneumonia
• At least 1 of the following:

• Fever
• Hypothermia
• 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:

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