SOLITAIRE-ORAL : Efficacy and safety of oral solithromycin versus oral moxifloxacin for treatment of community-acquired bacterial pneumonia: a global, double-blind, multicentre, randomised, active-controlled, non-inferiority trial.
2016年Lancet Infect Disに報告された、North America, Latin America, Europe, South Africa 114施設による成人の市中肺炎に対する非劣勢RCT.
- SOLITAIRE-ORAL : Efficacy and safety of oral solithromycin versus oral moxifloxacin for treatment of community-acquired bacterial pneumonia: a global, double-blind, multicentre, randomised, active-controlled, non-inferiority trial.
P : Patients (aged ≥18 years) with clinically and radiographically confirmed pneumonia of Pneumonia Outcomes Research Team (PORT) risk class II, III, or IV
E : oral solithromycin (800 mg on day 1, 400 mg on days 2-5, placebo on days 6-7)
C : oral moxifloxacin (400 mg on days 1-7)
O : Solithromycin was non-inferior to moxifloxacin in achievement of early clinical response: 333 (78·2%) patients had an early clinical response in the solithromycin group versus 338 (77·9%) patients in the moxifloxacin group (difference 0·29, 95% CI -5·5 to 6·1). Both drugs had a similar safety profile.
T : global (日本含まない) , double-blind, double-dummy, randomised, active-controlled, non-inferiority trial
olithromycin is a novel fourth-generation macrolide antibiotic and the first fluoroketolide. The drug is active against macrolide-resistant pneumococci, including strains with erm-mediated and mef-mediated resistance.Solithromycin is active against macrolide-resistant M pneumoniae, and against meticillin-sensitive and community-acquired meticillin-resistant S aureus strains, and has high potency for both extracellular and intracellular Legionella spp. Solithromycin also has potent anti-inflammatory effects, which might be beneficial in treatment of CABP.
Our study had some limitations. Patients were followed up for only 30 days, a limitation when considering the effect of CABP on long-term mortality. Because the study was done mainly in outpatients with comparisons of oral antibiotic therapies, the mean age and PORT score of patients was marginally lower than that reported in other trials with intravenous antibiotics.2,3 Although 10% of pneumococcal isolates were macrolide resistant (but solithromycin sensitive), the small overall number of macrolide-resistant cases limits the study’s ability to fully show solithromycin efficacy for these resistant strains. Strengths of this study include its double-blind, randomised design, the low attrition rate, enrolment from sites across the world, and the substantial efforts undertaken to establish a causal diagnosis in each patient, showing the importance of atypical pathogens.