Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia



Status:Archived
Conditions:Pneumonia
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:August 2010
End Date:June 2011

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A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Oral CEM-101 Compared to Oral Levofloxacin in the Treatment of Patients With Community-Acquired Bacterial Pneumonia


Study to evaluate the safety and efficacy of oral CEM-101 compared to oral Levofloxacin in
the treatment of adults with moderate to moderately severe community-acquired bacterial
pneumonia.


Community-acquired bacterial pneumonia 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 again CABP pathogens. CEM-101 is the first fluoroketolide with excellent in vitro
and in vivo activity against resistant S. pneumoniae and other key typical and atypical
bacterial respiratory pathogens.


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