gemifloxacin and Sinusitis

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).. 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).. 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.. 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.

Topics: Acute Disease; Administration, Oral; Adult; Anti-Infective Agents; Bacterial Infections; Confidence Intervals; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Fluoroquinolones; Follow-Up Studies; Gemifloxacin; Humans; Male; Middle Aged; Naphthyridines; Probability; Prospective Studies; Rhinitis; Sinusitis; Treatment Outcome

Topics: Acute Disease; Anti-Bacterial Agents; Carrier State; Chemical and Drug Induced Liver Injury; Female; Fluoroquinolones; Gemifloxacin; Hepatitis B Surface Antigens; Humans; Liver Function Tests; Middle Aged; Naphthyridines; Rhinitis; Risk Factors; Sinusitis; Treatment Outcome; Withholding Treatment

Using a microbroth method for aerobes and agar dilution for anaerobes, we studied the comparative in vitro activity of gemifloxacin, three fluoroquinolones, two macrolides and two beta-lactams, against 207 aerobic and 162 anaerobic antral sinus puncture isolates. Gemifloxacin was active at < or = 0.25 ug/mL against 198/207 [96%] aerobes and 127/162 [78%] anaerobes or 325/369 [88%] of all isolates and was the most active quinolone on a weight basis against Gram-positive organisms. All Haemophilus and Moraxella species were susceptible to < or =0.06 ug/mL of gemifloxacin. Thirty-five anaerobic isolates [35/162, 22%] required > or =0.5 ug/mL of gemifloxacin for inhibition, including all Prevotella species [all except one strain of P. bivia were susceptible to < or = 2 ug/mL] and occasional strains of Bacteroides uniformis, Bacteroides fragilis, Bilophila wadsworthia, Peptostreptococcus magnus, Peptostreptococcus micros, Propionibacterium acnes, and Veillonella species. All fusobacteria were susceptible to < or =0.25 ug/mL of gemifloxacin. Based on our in vitro study results, we conclude that gemifloxacin may offer a therapeutic alternative for sinus infections.

Topics: Anti-Bacterial Agents; Anti-Infective Agents; Bacteria, Aerobic; Bacteria, Anaerobic; Drug Resistance, Bacterial; Fluoroquinolones; Gemifloxacin; Humans; Maxillary Sinus; Microbial Sensitivity Tests; Naphthyridines; Punctures; Sinusitis