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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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01968733
Study type Interventional
Source Cempra Inc
Contact
Status Completed
Phase Phase 3
Start date November 2013
Completion date September 2015

See also
  Status Clinical Trial Phase
Recruiting NCT06162286 - A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP Phase 3
Completed NCT01072539 - Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment
Completed NCT01756339 - Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia Phase 3
Completed NCT01371838 - A Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia Phase 3
Completed NCT01168713 - Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia Phase 2
Terminated NCT02605122 - Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia Phase 2/Phase 3