Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia (SOLITAIRE-ORAL)
This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.
Community-acquired Bacterial Pneumonia
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Early clinical response rate in the Intent to Treat (ITT) population [ Time Frame: 72 [±12] hours after the first dose of study drug ] [ Designated as safety issue: No ]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.
- Early clinical response rate in the microITT population [ Time Frame: 72 [±12] hours after the first dose of study drug ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]To determine the overall clinical success rates of oral solithromycin compared to moxifloxacin
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Solithromycin 800 mg orally (PO) on Day 1 followed by 400 mg PO daily on Days 2 through 5, followed by placebo on Days 6 and 7
Other Name: CEM-101
Active Comparator: Moxifloxacin
Moxifloxacin 400 mg PO daily on Day 1 through Day 7
Other Name: Avelox
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756339
|Contact: Kay Clark, RNemail@example.com|
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