Oral gemifloxacin once daily for 5 days compared with sequential therapy with i.v. ceftriaxone/oral cefuroxime (maximum of 10 days) in the treatment of hospitalized patients with acute exacerbations of chronic bronchitis

Abstract

In a randomized, open-label, controlled, multicentre study, the clinical and bacteriological efficacy, safety and tolerability of oral gemifloxacin (320 mg once daily, 5 days) was compared with sequential intravenous (i.v.) ceftriaxone (1 g once daily, maximum 3 days) followed by oral cefuroxime axetil (500 mg twice daily, maximum 7 days) in adult hospitalized patients with acute exacerbations of chronic bronchitis (AECB) (n = 274). The clinical success rates at follow-up (21-28 days post-therapy) in the clinical per-protocol population (the primary endpoint) were 86.8% (105/121) for gemifloxacin vs. 81.3% (91/112) for ceftriaxone/cefuroxime (treatment difference = 5.5,95% CI -3.9,14.9). The corresponding clinical results in the clinical intention-to-treat (ITT) population were 82.6% (114/138) vs. 72.1% (98/136), respectively (treatment difference = 10.5,95% CI 0.7, 20.4).Thus, gemifloxacin had significantly higher clinical success rates than ceftriaxone/cefuroxime. The median time to discharge was 9 days in the gemifloxacin group vs. 11 days in the ceftriaxone/cefuroxime group (P = 0.04, Wilcoxon test). At follow-up, 120/138 (87.0%) gemifloxacin-treated patients had been discharged from hospital, compared with 111/136 (81.6%) ceftriaxone/cefuroxime-treated patients in the clinical ITT population. Both treatments were generally well tolerated and there was no significant difference between the treatment groups in the incidence or type of adverse events reported. A 5-day course of oral gemifloxacin was shown by this study to be at least equivalent to sequential i.v. ceftriaxone/cefuroxime axetil (for up to 10 days) in patients with AECB who require hospital treatment.

Comparative effectiveness of macrolides and quinolones for patients hospitalized with acute exacerbations of chronic obstructive pulmonary disease (AECOPD)

“…Others have also documented an association between fluoroquinolones and C. difficile diarrhea. [28][29][30] This trend, first noted in 2001, is of particular concern because the fluoroquinolone-resistant strains appear to be hypervirulent and have been associated with nosocomial epidemics. [31][32][33][34] Our study has several limitations.…”

Antimicrobial activity and a comparison of published pharmacodynamics of gemifloxacin and eight fluoroquinolones against Streptococcus pneumoniae

“…However, several trials to date support the efficacy of gemifloxacin in the treatment of lower respiratory tract infections [13,14].…”

Gemifloxacin use in the treatment of acute bacterial exacerbation of chronic bronchitis

“…In 2003, Wilson and colleagues compared the activity of gemifloxacin with that of IV ceftriaxone/oral cefuroxime in the treatment of 271 hospitalized patients with AECB. 49 The clinical success rates at follow-up were 86.8% for gemifloxacin vs. 81.3% for ceftriaxone/cefuroxime in the entire study population (treatment difference = 5.5; 95% confidence interval [CI]: -3.9, 14.9). In the clinical intention-to-treat (ITT) population the clinical results were 82.6% vs. 72.1% (95% CI: 0.7, 20.4).…”

“…These clinical trials, although intended to show the noninferiority of gemifloxacin, identified some clinically significant differences between gemifloxacin and comparator drugs: decreased length of hospitalization versus ceftriaxone/cefuroxime; 49 shorter time to eradication of H. influenzae when compared with clarithromycin; 50 increased bacteriological success rate in AECB when compared to amoxicillin/clavulanate. 51 More importantly for our purposes of comparing gemifloxacin with other fluoroquinolones, gemifloxacin had a higher clinical success rate when compared to trovafloxacin, 52 and a higher rate of success versus levofloxacin at long-term follow-up 54 in two high quality trials (both trials get high scores on Jadad scale).…”