NCT01756339

Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 860 (actual)
• Sponsor: Melinta Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.

Detailed description

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.

Conditions

• Community-acquired Bacterial Pneumonia

Interventions

Type	Name	Description
DRUG	Solithromycin
DRUG	Moxifloxacin
OTHER	Placebo to match solithromycin

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2012-12-25
• Last updated: 2017-03-03

Locations

119 sites across 17 countries: United States, Argentina, Bulgaria, Canada, Czechia, Dominican Republic, Ecuador, Estonia, Germany, Hungary, Latvia, Poland, Puerto Rico, Romania, Russia, South Africa, Spain