NCT01168713

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Melinta Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Community-Acquired Bacterial Pneumonia

Interventions

Type	Name	Description
DRUG	Levofloxacin	Levofloxacin once daily for 5 days: Levofloxacin 750 mg PO Days 1-5
DRUG	CEM-101	CEM-101 once daily for 5 days: CEM-101 800 mg PO Day 1 CEM-101 400 mg PO Days 2-5

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-07-23
• Last updated: 2017-03-03

Locations

55 sites across 2 countries: United States, Canada