Clinical Trial: Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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-Acqui

Brief 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 Summary: 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.
Sponsor: Cempra Inc

Current Primary Outcome: Early clinical response rate in the Intent to Treat (ITT) population [ Time Frame: 72 [±12] hours after the first dose of study drug ]

To determine noninferiority (NI) in early clinical response rate, in at least 2 of the following 4 cardinal symptoms: cough, shortness of breath, chest pain, and sputum production.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Early clinical response rate in the microITT population [ Time Frame: 72 [±12] hours after the first dose of study drug ]
    To determine NI in early clinical response rate of oral solithromycin compared to oral moxifloxacin in the mITT population
  • Clinical success rates in the ITT and Clincally Evaluable (CE) populations [ Time Frame: 5 to 10 days after the last dose of study drug ]
    To determine the overall clinical success rates of oral solithromycin compared to moxifloxacin


Original Secondary Outcome: Same as current

Information By: Cempra Inc

Dates:
Date Received: December 20, 2012
Date Started: December 2012
Date Completion:
Last Updated: March 1, 2017
Last Verified: March 2017