title: SOLITAIRE-IV: A Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous-to-Oral Solithromycin to Intravenous-to-Oral Moxifloxacin for Treatment of Community-Acquired Bacterial Pneumonia.
abstract: Solithromycin, a novel macrolide antibiotic with both intravenous and oral formulations dosed once daily, has completed 2 global phase 3 trials for treatment of community-acquired bacterial pneumonia.
  
  
  
  A total of 863 adults with community-acquired bacterial pneumonia (Pneumonia Outcomes Research Team [PORT] class II-IV) were randomized 1:1 to receive either intravenous-to-oral solithromycin or moxifloxacin for 7 once-daily doses. All patients received 400 mg intravenously on day 1 and were permitted to switch to oral dosing when clinically indicated. The primary objective was to demonstrate noninferiority (10% margin) of solithromycin to moxifloxacin in achievement of early clinical response (ECR) assessed 3 days after first dose in the intent-to-treat (ITT) population. Secondary endpoints included demonstrating noninferiority in ECR in the microbiological ITT population (micro-ITT) and determination of investigator-assessed success rates at the short-term follow-up (SFU) visit 5-10 days posttherapy.
  
  
  
  In the ITT population, 79.3% of solithromycin patients and 79.7% of moxifloxacin patients achieved ECR (treatment difference, -0.46; 95% confidence interval [CI], -6.1 to 5.2). In the micro-ITT population, 80.3% of solithromycin patients and 79.1% of moxifloxacin patients achieved ECR (treatment difference, 1.26; 95% CI, -8.1 to 10.6). In the ITT population, 84.6% of solithromycin patients and 88.6% of moxifloxacin patients achieved clinical success at SFU based on investigator assessment. Mostly mild/moderate infusion events led to higher incidence of adverse events overall in the solithromycin group. Other adverse events were comparable between treatment groups.
  
  
  
  Intravenous-to-oral solithromycin was noninferior to intravenous-to-oral moxifloxacin. Solithromycin has potential to provide an intravenous and oral option for monotherapy for community-acquired bacterial pneumonia.
  
  
  
  NCT01968733.
authors.affiliation: Summa Health System and Northeast Ohio Medical University, Rootstown, Ohio.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: File
authors.affiliation: Diamond Clinic, Cracow, Poland.
authors.forename: Barbara
authors.initials: B
authors.lastname: Rewerska
authors.affiliation: Medical School, University of Belgrade and University Hospital of Lung Diseases, Clinical Center of Serbia.
authors.forename: Violeta
authors.initials: V
authors.lastname: Vucinic-Mihailovic
authors.affiliation: Lung Center of the Philippines, Quezon City, Metro Manila.
authors.forename: Joven Roque V
authors.initials: JRV
authors.lastname: Gonong
authors.affiliation: Das Consulting, San Francisco, California.
authors.forename: Anita F
authors.initials: AF
authors.lastname: Das
authors.affiliation: Cempra Inc, Chapel Hill, North Carolina.
authors.forename: Kara
authors.initials: K
authors.lastname: Keedy
authors.affiliation: Cempra Inc, Chapel Hill, North Carolina.
authors.forename: David
authors.initials: D
authors.lastname: Taylor
authors.affiliation: Cempra Inc, Chapel Hill, North Carolina.
authors.forename: Amanda
authors.initials: A
authors.lastname: Sheets
authors.affiliation: Cempra Inc, Chapel Hill, North Carolina.
authors.forename: Prabhavathi
authors.initials: P
authors.lastname: Fernandes
authors.affiliation: Cempra Inc, Chapel Hill, North Carolina.
authors.forename: David
authors.initials: D
authors.lastname: Oldach
authors.affiliation: Cempra Inc, Chapel Hill, North Carolina.
authors.forename: Brian D
authors.initials: BD
authors.lastname: Jamieson
mesh_terms: D061605:Administration, Intravenous; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D017714:Community-Acquired Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology*; D015897:Comorbidity; D024881:Drug Resistance, Bacterial; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D018942:Macrolides / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D000077266:Moxifloxacin; D018410:Pneumonia, Bacterial / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology*; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; D018942:Macrolides; D014230:Triazoles; C547755:solithromycin; D000077266:Moxifloxacin
keywords: Streptococcus pneumoniae; clinical trial; community-acquired; pneumonia; solithromycin