JAC Advance Access first published online on May 30, 2007
This version published online on June 5, 2007
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkm119
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Gemifloxacin once daily for 5 days versus 7 days for the treatment of community-acquired pneumonia: a randomized, multicentre, double-blind study
1 Northeastern Ohio Universities College of Medicine, Rootstown, OH and Summa Health System, 75 Arch Street, Suite 105, Akron, OH 44304, USA 2 McMaster University School of Medicine, 711 Concession Street, Hamilton, Ontario, L8V1C3 Canada 3 Oscient Pharmaceuticals Corporation, 1000 Winter Street, Suite 2200, Waltham, MA 02451, USA 4 Military Medical Academy, Pulmonary Clinic, 3 Georgi Sofijski Street, Sofia 1606, Bulgaria 5 Alexandrovska University Multiprofile Hospital for Active Treatment, Propedeutics and Internal Diseases Department, Pulmonary Clinic, 1 Georgi Sofijski Street, Sofia 1431, Bulgaria
Received 10 October 2006; returned 26 November 2006; revised 27 March 2007; accepted 29 March 2007
* Corresponding author. Tel: +1-330-375-3894; Fax: +1-330-375-6680; E-mail: filet{at}summa-health.org
Objectives: Short-course therapy has been advocated for the treatment of community-acquired pneumonia (CAP). We compared the efficacy and safety of 5 and 7 day courses of gemifloxacin for outpatient treatment of mild–moderate CAP.
Patients and methods: In a multicentre, double-blind, parallel group study, patients were randomized to receive 320 mg of oral gemifloxacin once daily for 5 or 7 days. Over 95% of all patients in each cohort had a Fine score of 
III. The primary efficacy endpoint was clinical cure at follow-up (days 24–30). Secondary outcomes were clinical and bacteriological responses at the end of therapy (days 7–9) and bacteriological and radiological responses at follow-up. Adverse events (AEs) were also monitored.
Results: In a total of 469 per protocol (PP) patients, clinical resolution at follow-up was 95% and 92% for 5 and 7 day treatments, respectively [95% confidence interval (CI) –1.48, 7.42], indicating non-inferiority of 5 day treatment. Clinical resolution at the end of therapy was 96% for both regimens (95% CI –3.85, 3.42). Bacteriological response rates in PP patients at the end of therapy were 94% and 96% for 5 and 7 day groups, respectively (95% CI –8.27, 3.25) and 91% for both groups at follow-up (95% CI –6.89, 7.93). Radiological success in PP patients at follow-up was 98% and 93% in 5 and 7 day groups, respectively (95% CI 0.35, 7.91). Pre-therapy pathogens were identified in 242 (47.3%) patients, most commonly Streptococcus pneumoniae. Frequency of treatment-related AEs was 21% in both cohorts with discontinuation rates of 1.2% and 2% in the 5 and 7 day groups, respectively. A lower incidence of rash was observed in the 5 day cohort (0.4%) versus the 7 day cohort (2.8%) (P = 0.04).
Conclusions: Gemifloxacin once daily for 5 days is not inferior to 7 days in the PP population with respect to clinical, bacteriological and radiological efficacy. Further work is needed, however, to explore whether fewer treatment days would improve patient compliance and reduce the incidence of AEs.
Key Words: fluoroquinolones , short-course therapy , Phase III , resistance , CAP
Present address. Replidyne Pharmaceuticals, Louisville, CO, USA. This paper had been incorrectly published under the Open Access model. It is published with standard subscription-based access.
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  M. R. Hammerschlag Comment on: Gemifloxacin once daily for 5 days versus 7 days for the treatment of community-acquired pneumonia: a randomized, multicentre, double-blind study J. Antimicrob. Chemother., October 1, 2007; 60(4): 902 - 903. [Full Text] [PDF]
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T. M. File, L. A. Mandell, and G. Tillotson Gemifloxacin once daily for 5 days versus 7 days for the treatment of community-acquired pneumonia: a randomized, multicentre, double-blind study authors' response J. Antimicrob. Chemother., October 1, 2007; 60(4): 903 - 903. [Full Text] [PDF]
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