OBJECTIVE: The primary objective of this study was to demonstrate the clinical and radiologic efficacy of 5 days compared with 7 days of gemifloxacin therapy in the treatment of acute bacterial rhinosinusitis (ABRS). STUDY DESIGN: In this prospective, double-blind, multicenter, parallel-group study, adult patients presenting with ABRS were randomized to receive gemifloxacin 320 mg once daily for either 5 days (n = 218) or 7 days (n = 203). RESULTS: For the primary efficacy end point, clinical response to therapy at follow-up, 5 days of therapy with gemifloxacin was as effective as 7 days of therapy (per-protocol population; treatment difference 0.44%; 95% confidence interval [CI], -6.54 to 7.41). Five and 7 days of treatment with gemifloxacin were well tolerated. CONCLUSION AND SIGNIFICANCE: The clinical efficacy of gemifloxacin 320 mg daily for 5 days is at least as good as the efficacy of gemifloxacin 320 mg daily for 7 days in the treatment of ABRS.
RCT Entities:
OBJECTIVE: The primary objective of this study was to demonstrate the clinical and radiologic efficacy of 5 days compared with 7 days of gemifloxacin therapy in the treatment of acute bacterial rhinosinusitis (ABRS). STUDY DESIGN: In this prospective, double-blind, multicenter, parallel-group study, adult patients presenting with ABRS were randomized to receive gemifloxacin 320 mg once daily for either 5 days (n = 218) or 7 days (n = 203). RESULTS: For the primary efficacy end point, clinical response to therapy at follow-up, 5 days of therapy with gemifloxacin was as effective as 7 days of therapy (per-protocol population; treatment difference 0.44%; 95% confidence interval [CI], -6.54 to 7.41). Five and 7 days of treatment with gemifloxacin were well tolerated. CONCLUSION AND SIGNIFICANCE: The clinical efficacy of gemifloxacin 320 mg daily for 5 days is at least as good as the efficacy of gemifloxacin 320 mg daily for 7 days in the treatment of ABRS.
Authors: Martin Desrosiers; Gerald A Evans; Paul K Keith; Erin D Wright; Alan Kaplan; Jacques Bouchard; Anthony Ciavarella; Patrick W Doyle; Amin R Javer; Eric S Leith; Atreyi Mukherji; R Robert Schellenberg; Peter Small; Ian J Witterick Journal: Allergy Asthma Clin Immunol Date: 2011-02-10 Impact factor: 3.406
Authors: Matthew E Falagas; Drosos E Karageorgopoulos; Alexandros P Grammatikos; Dimitrios K Matthaiou Journal: Br J Clin Pharmacol Date: 2008-09-19 Impact factor: 4.335
Authors: Horacio Ariza; Ramon Rojas; Peter Johnson; Richard Gower; Alice Benson; Janet Herrington; Renee Perroncel; Peter Pertel Journal: BMC Ear Nose Throat Disord Date: 2006-04-28