Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia — SOLITAIRE-ORAL  

Community-acquired Bacterial Pneumonia Clinical Trial

Official title: 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

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Community-acquired Bacterial Pneumonia
• Pneumonia
• Pneumonia, Bacterial

• NCT number: NCT01756339
• Study type: Interventional
• Source: Cempra Inc
• Status: Completed
• Phase: Phase 3
• Start date: December 2012
• Completion date: October 2014