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

Community-Acquired Bacterial Pneumonia Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Community-Acquired Bacterial Pneumonia
• Pneumonia
• Pneumonia, Bacterial

• NCT number: NCT01168713
• Study type: Interventional
• Source: Cempra Inc
• Status: Completed
• Phase: Phase 2
• Start date: August 2010
• Completion date: July 2011