Journal Article

Once-Daily, High-Dose Levofloxacin versus Ticarcillin-Clavulanate Alone or Followed by Amoxicillin-Clavulanate for Complicated Skin and Skin-Structure Infections: A Randomized, Open-Label Trial

Donald R Graham, David A Talan, Ronald L Nichols, Christopher Lucasti, Michael Corrado, Nancy Morgan and Cynthia L Fowler

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 35, issue 4, pages 381-389
Published in print August 2002 | ISSN: 1058-4838
Published online August 2002 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/341026
Once-Daily, High-Dose Levofloxacin versus Ticarcillin-Clavulanate Alone or Followed by Amoxicillin-Clavulanate for Complicated Skin and Skin-Structure Infections: A Randomized, Open-Label Trial

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This study tested whether levofloxacin, at a new high dose of 750 mg, was effective for the treatment of complicated skin and skin-structure infections (SSSIs). Patients with complicated SSSIs (n = 399) were randomly assigned in a ratio of 1 : 1 to 2 treatment arms: levofloxacin (750 mg given once per day intravenously [iv], orally, or iv/orally) or ticarcillin-clavulanate (TC; 3.1 g given iv every 4–6 hours) followed, at the investigator's discretion, by amoxicillin-clavulanate (AC; 875 mg given orally every 12 hours). In the clinically evaluable population, therapeutic equivalence was demonstrated between the levofloxacin and TC/AC regimens (success rates of 84.1% and 80.3%, respectively). In the microbiologically evaluable population, the overall rate of eradication was 83.7% in the levofloxacin treatment group and 71.4% in the TC/AC treatment group (95% confidence interval, -24.3 to -0.2). Both levofloxacin and TC/AC were well tolerated. These data demonstrate that levofloxacin (750 mg once per day) is safe and at least as effective as TC/AC for complicated SSSIs

Journal Article.  4307 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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