Trials / Completed
CompletedNCT01968733
Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous 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 Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 863 (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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Solithromycin | |
| DRUG | Moxifloxacin |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2015-07-01
- Completion
- 2015-09-01
- First posted
- 2013-10-24
- Last updated
- 2017-03-03
Locations
270 sites across 26 countries: United States, Argentina, Bulgaria, Canada, Chile, Colombia, Georgia, Germany, Guatemala, Hungary, Latvia, Malaysia, Netherlands, Peru, Philippines, Poland, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Taiwan, Ukraine
Source: ClinicalTrials.gov record NCT01968733. Inclusion in this directory is not an endorsement.