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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
860
Early clinical response rate in the Intent to Treat (ITT) population
To determine noninferiority (NI) in early clinical response rate, in at least 2 of the following 4 cardinal symptoms: cough, shortness of breath, chest pain, and sputum production.
Time frame: 72 [±12] hours after the first dose of study drug
Early clinical response rate in the microITT population
To determine NI in early clinical response rate of oral solithromycin compared to oral moxifloxacin in the mITT population
Time frame: 72 [±12] hours after the first dose of study drug
Clinical success rates in the ITT and Clincally Evaluable (CE) populations
To determine the overall clinical success rates of oral solithromycin compared to moxifloxacin
Time frame: 5 to 10 days after the last dose of study drug
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Glendale, California, United States
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Los Angeles, California, United States
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Mission Hills, California, United States
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Oxnard, California, United States
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Pasadena, California, United States
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Sylmar, California, United States
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Torrance, California, United States
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DeBary, Florida, United States
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DeLand, Florida, United States
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Miami, Florida, United States
...and 109 more locations