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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

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      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.

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      REFERENCES

        • Ball P
        Epidemiology and treatment of chronic bronchitis and its exacerbations.
        Chest. 1995; 108: 43S-52S
        • Niederman MS
        • McCombs JS
        • Unger AN
        • Kumar A
        • Popovian R
        Treatment costs of acute exacerbations of chronic bronchitis.
        Clin Ther. 1999; 21: 576-591
        • Ball P
        • Harris JM
        • Lowson D
        Acute infective exacerbations of chronic bronchitis: study of outcome by clinical parameters.
        Q J Med. 1995; 88: 61-68
        • Pechère J-C
        • Lacey L
        Optimizing economic outcomes in antibiotic therapy of patients with acute bacterial exacerbations of chronic bronchitis.
        J Antimicrob Chemother. 2000; 45: 19-24
        • Dagan R
        • Klugman KP
        • Craig WA
        • Baquero F
        Evidence to support the rationale that bacterial eradication in respiratory tract infection is an important aim of antimicrobial therapy.
        J Antimicrob Chemother. 2001; 47: 129-140
        • McGuire A
        Burden and cost of LRTI: a methodologic overview.
        Infect Med. 1998; 15: 26-31
        • Vogel F
        Cost benefits from improving clinical outcome.
        Infect Med. 1998; 15: 61-67
        • Nathwani D
        • Tillotson G
        • Davey P
        Sequential antimicrobial therapy—the role of quinolones.
        J Antimicrob Chemother. 1997; 39: 441-446
        • Collingnon PJ
        Intravascular catheter associated sepsis: a common problem. The Australian Study on Intravascular Catheter Associated Sepsis.
        Med J Aust. 1994; 161: 374-378
        • Vogel F
        Sequential therapy in the hospital management of lower respiratory infections.
        Am J Med. 1995; 99: 14S-19S
        • Grossman RF
        Guidelines for the treatment of acute exacerbations of chronic bronchitis.
        Chest. 1997; 112: 310S-313S
        • Grossman RF
        How do we achieve cost-effective options in lower respiratory tract infection therapy?.
        Chest. 1998; 113: 205S-210S
        • Hoban DJ
        • Bouchillon SK
        • Karlowsky JA
        A comparative in vitro surveillance study of gemifloxacin activities against 2,632 recent Streptococcus pneumoniae isolates from across Europe, North America, and South America.
        Antimicrob Agents Chemother. 2000; 44: 3008-3011
        • Chen DK
        • McGeer A
        • De Azavedo JC
        • Low DE
        Decreased susceptibility of Streptococcus pneumoniae to fluoroquinolones in Canada.
        N Engl J Med. 1999; 341: 233-239
        • File T
        • Schlemmer B
        • Garau J
        Gemifloxacin versus amoxicillin/clavulanate in the treatment of acute exacerbations of chronic bronchitis.
        J Chemother. 2000; 12: 314-325
        • Ball P
        • Wilson R
        • Mandell L
        • Brown J
        • Henkel T
        Efficacy of gemifloxacin in acute exacerbations of chronic bronchitis: a randomised, double-blind comparison with trovafloxacin.
        J Chemother. 2001; 13: 288-298
        • Wilson R
        • Schentag JJ
        • Ball P
        • Mandell L
        A comparison of gemifloxacin and clarithromycin in acute exacerbations of chronic bronchitis and long-term clinical outcomes.
        Clin Ther. 2002; 24: 639-652
        • Ball P
        • File TM
        • Twynholm M
        • Henkel T
        Efficacy and safety of gemifloxacin 320 mg once-daily for 7 days in the treatment of lower respiratory tract infections.
        Int J Antimicrob Agents Chemother. 2001; 18: 19-27
        • Vogel F
        • Droszcz W
        • Vondra V
        • Reisenberg K
        • Marr C
        • Staley H
        Sequential therapy with cefuroxime followed by cefuroxime axetil in acute exacerbations of chronic bronchitis.
        J Antimicrob Chemother. 1997; 40: 863-871
        • Janknegt R
        • van der Meer J WM
        Antimicrobial practice: sequential therapy with intravenous and oral cephalosporins.
        J Antimicrob Chemother. 1994; 33: 169-177
      1. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically. Approved Standard M7-A4. NCCLS, Wayne1997
      2. Performance Standards for Antimicrobial Disk Susceptibility Tests; Eighth Informational Supplement. Approved Standard M100-S8. NCCLS, Wayne1998
        • Moss AJ
        Measurement of the QT interval and the risk associated with QTc interval prolongation: a review.
        Am J Cardiol. 1993; 72: 23B-25B
        • Smyth E TM
        • Barr JG
        • O-Neill CA
        • Hogg GM
        An assessment of hidden and total antibiotic costs of four parenteral cephalosporins.
        PharmacoEconomics. 1995; 8: 541-550
        • Garau J
        Clinical failures: the tip of the iceberg?.
        Resp Med. 2001; 95: S5-S11
        • Lee BL
        • Padula AM
        • Kimbrough RC
        Infectious complications with respiratory pathogens despite ciprofloxacin therapy.
        N Engl J Med. 1991; 325: 520-521
        • Davies BI
        • Maesen F PV
        Clinical effectiveness of levofloxacin in patients with acute purulent exacerbations of chronic bronchitis: the relationship with in-vitro activity.
        J Antimicrob Chemother. 1999; 43: 83-90
        • Berry V
        • Page R
        • Satterfield J
        • Singley C
        • Straub R
        • Woodnutt G
        Comparative efficacy of gemifloxacin (SB-265805) against experimental respiratory tract infection in rats caused by ciprofloxacin-resistant strains of Streptococcus pneumoniae and Haemophilus influenzae.
        Abstracts of the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy. September 26 29, 1999; : 76
      3. Cupo, M, Pypstra, R, Young, C, Safety of gemifloxacin in adult patients with respiratory and urinary tract infections, Seventh Conference of the Federation of Infection Societies, 29 November–1 December 2000