Journal of Antimicrobial Chemotherapy (2001) 48, 67-74
© 2001 The British Society for Antimicrobial Chemotherapy
Efficacy and safety of gemifloxacin in the treatment of community-acquired pneumonia: a randomized, double-blind comparison with trovafloxacin
a Summa Health System, Akron Infectious Disease Inc., 75 Arch Street, Suite 105 Akron, OH 44304, USA; b Hôpital St Louis, Paris, France; c Hospital Mutua de Terassa, Barcelona, Spain; d SmithKline Beecham, Collegeville, PA, USA
This multicentre, randomized, double blind, parallel group study compared the efficacy and safety of gemifloxacin (320 mg once daily) with trovafloxacin (200 mg once daily) in 571 patients with community-acquired pneumonia (CAP). Although treatment was given routinely for 7 days it could be extended to 14 days; two-thirds of patients were treated for 7 days. High clinical success rates were noted at follow-up in the per-protocol population in both the gemifloxacin group (95.8%) and the trovafloxacin group (93.6%), non-inferiority with 95% CI. In the intentto-treat population, the clinical success rate at follow-up was significantly superior for gemifloxacin (87.6%) compared with trovafloxacin (81.1%; 95% CI 0.5, 12.4). The pathogens identified most commonly at presentation were Mycoplasma pneumoniae and Streptococcus pneumoniae. Gemifloxacin eradicated 100% of S. pneumoniae. One bacteraemic isolate of S. pneumoniae was associated with clinical failure in the trovafloxacin group (MIC of trovafloxacin 8 mg/L). Gemifloxacin was well tolerated and the incidence of transient liver function abnormalities was very low. Gemifloxacin is an effective and well-tolerated treatment for patients with CAP.
* Corresponding author. Tel: +1-330-375-3894: Fax: +1-330-375-3161; E-mail: filet{at}summa-health.org
Members of the 049 Clinical Study Group are listed in the Acknowledgements.
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