Study Name/Number: SOLITAIRE-IV
Title: 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
Investigator: Stanley A. Link, MD
Purpose: The purpose of this study is to determine noninferiority (NI) in early clinical response rate (defined as improvement at 72 [+12] hours after the first dose of study drug), in at least 2 of the following 4 cardinal symptoms: cough, shortness of breath, chest pain, and sputum production, (without worsening of any) of intravenous (IV) to oral solithromycin compared to IV to oral moxifloxacin in adult patients with community-acquired bacterial pneumonia (CABP) in the intent to Treat (ITT) population.
Link to the current ClinicalTrials.gov record »