Compared with Linezolid for Treatment of Acute Bacterial ... the efficacy of JNJ-Q2 (250 mg, twice a day [BID]) versus linezolid (600 mg, BID) in patients with ...
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, Dec. 2011, p. 5790–5797 0066-4804/11/$12.00 doi:10.1128/AAC.05044-11 Copyright © 2011, American Society for Microbiology. All Rights Reserved.
Vol. 55, No. 12
Randomized, Double-Blind, Phase II, Multicenter Study Evaluating the Safety/Tolerability and Efficacy of JNJ-Q2, a Novel Fluoroquinolone, Compared with Linezolid for Treatment of Acute Bacterial Skin and Skin Structure Infection䌤† Paul Covington,1* J. Michael Davenport,1 David Andrae,1 William O’Riordan,2 Lisa Liverman,1 Gail McIntyre,1 and June Almenoff1 Furiex Pharmaceuticals, Morrisville, North Carolina,1 and eStudySite, San Diego, California2 Received 8 June 2011/Returned for modification 15 August 2011/Accepted 15 September 2011
JNJ-Q2 is a fluoroquinolone with broad coverage including methicillin-resistant Staphylococcus aureus (MRSA). A double-blind, multicenter, phase II noninferiority study treated 161 patients for 7 to 14 days, testing the efficacy of JNJ-Q2 (250 mg, twice a day [BID]) versus linezolid (600 mg, BID) in patients with acute bacterial skin and skin structure infections (ABSSSI). The prespecified criterion for noninferiority was 15%. Primary intent-to-treat analysis was unable to declare noninferiority, as the risk difference lower bound of the 95% confidence interval between treatments was 19% at 36 to 84 h postrandomization for the composite end point of lesion assessment and temperature. Prespecified clinical cure rates 2 to 14 days after completion of therapy were similar (83.1% for JNJ-Q2 versus 82.1% for linezolid). Post hoc analyses revealed that JNJ-Q2 was statistically noninferior to linezolid (61.4% versus 57.7%, respectively; P ⴝ 0.024) based on the 2010 FDA guidance, which defines treatment success as lack of lesion spread and afebrile status within 48 to 72 h postrandomization. Despite evidence of systemic disease,
