Single Intravenous Dose of Oritavancin for Treatment of Acute Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: Summary of Safety Analysis from the Phase 3 SOLO Studies
Authors: Corey G. Ralph , Loutit Jeffery , Moeck Greg , Wikler Matthew , Dudley Michael N. , O'Riordan William ,   SOLO I and SOLO II investigators, Fortun Abete Jesús , Altmeyer Peter , Basson Marc D. , Bezrodnyi Borys G. , Brennan Robert O. , Bubnova Natalia A. , Chandra Abhijit , Chandrasekharan Ashok Annadan , Chen James , Condrea Constantin , del Rayo Morfin Maria , DeValle Oscar , Dunbar LaLa , Duttarroy Dipesh , Giordano Philip , Gonzalez Julian , Gorgolas Miguel , Graham Donald R. , Green Sinikka , Gudz Ivan , Kumar Gupta Sandeep , Heller Barry N. , Hussein Osamah , Jauregui-Peredo Luis , Kabler Heidi , Kazimir Michal , Keech Richard C. , Kelkar Dhananjay , Konychev Alexander V. , Koura Firas , Kozlov Roman S. , Laboranti Maria C. , Lakhani Rajendra J. , Lee Patrick C. , Leiman David , Leiva Jorge , Lenskaya Liudmila G. , Levchik Evgeniy Y. , Lombana-Martinez Clara , Lucasti Christopher , Mahakalkar Chandrashekhar C. , Mannis Steven H. , Manos Paul J. , Marinescu Silviu Adrian , Mayakonda Ramesh K. , McKinnell James , Mehra Purvi , Minkowitz Harold , Nagappa Yogishwarappa Chowdipallaya , Nolan Patrick , Osiyemi Olayemi , Overcash J. Scott , Porwal Ashwin Dhanrajji , Pullman John , Pyptiuk Oleksandr , Perez Nora Quintero , Rahav Galia , Ramachandra Hariprasad Taluru , Reinhardt John , Riesenberg Klaris , Rodoman Grigory , Romero-Cabello Raul , Rozario Anthony P. , Shah Mohd Yunus A. Salar , Sandesc Dorel , Schlesinger Yechiel , Sears Wade K. , Shapoval Sergiy D. , Shulutko Alexander , Sims Matthew , Singh Rajesh , Stenstrom Robert J. , Tuckler Victor , Voigt David , Zaichuk Anatolii , Zeltser David , Zubareva. Nadezhda A. 
Published: January 2018

ABSTRACT
Oritavancin is a lipoglycopeptide with bactericidal activity against Gram-positive organisms. Its rapid concentration-dependent bactericidal activity and long elimination half-life allow single-dose treatment of acute bacterial skin and skin structure infections (ABSSSI). SOLO I and SOLO II were randomized, double-blind studies evaluating the efficacy and safety of a single 1,200-mg intravenous (i.v.) dose of oritavancin versus twice-daily i.v. vancomycin for 7 to 10 days in ABSSSI patients. Safety data from both studies were pooled for safety analysis. The database comprised pooled safety data for 976 oritavancin-treated patients and 983 vancomycin-treated patients. The incidences of adverse events, serious adverse events, and discontinuations due to adverse events were similar for oritavancin (55.3, 5.8, and 3.7%, respectively) and vancomycin (56.9, 5.9, and 4.2%, respectively). The median time to onset (3.8 days versus 3.1 days, respectively) and the duration (3.0 days for both groups) of adverse events were also similar between the two groups. The most frequently reported events were nausea, headache, and vomiting. Greater than 90% of all events were mild or moderate in severity. There were slightly more infections and infestations, abscesses or cellulitis, and hepatic and cardiac adverse events in the oritavancin group; however, more than 80% of these events were mild or moderate. Subgroup analyses did not identify clinically meaningful differences in the incidence of adverse events attributed to oritavancin. A single 1,200-mg dose of oritavancin was well tolerated and had a safety profile similar to that of twice-daily vancomycin. The long elimination half-life of oritavancin compared to that of vancomycin did not result in a clinically meaningful delay to the onset or prolongation of adverse events. (This study has been registered at ClinicalTrials.gov under registration no. NCT01252719 and NCT01252732.)