A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia
A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia
This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired 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):
At least 1 of the following:
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:
Known HIV or myasthesia gravis
Caba, C1120AAF, Argentina
Saint Petersburg, Leningradskaya Oblast' 194354, Russia
Saint Petersburg, Leningradskaya Oblast' 196211, Russia
Saint Petersburg, Leningradskaya Oblast' 198205, Russia