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.

Abstract

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.

• Authors: Donald R Graham, David A Talan, Ronald L Nichols, Christopher Lucasti, Michael Corrado, Nancy Morgan, Cynthia L Fowler
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 35 Issue 4 Pg. 381-9 (Aug 15 2002) ISSN: 1537-6591 [Electronic] United States
• PMID: 12145720 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Infective Agents
• Clavulanic Acids
• Levofloxacin
• Amoxicillin-Potassium Clavulanate Combination
• ticarcillin-clavulanic acid
• Ofloxacin
• Ticarcillin

Topics

• Amoxicillin-Potassium Clavulanate Combination (administration & dosage, adverse effects, therapeutic use)
• Anti-Infective Agents (administration & dosage, adverse effects, therapeutic use)
• Clavulanic Acids (administration & dosage, adverse effects, therapeutic use)
• Drug Therapy, Combination (administration & dosage, adverse effects, therapeutic use)
• Female
• Humans
• Levofloxacin
• Male
• Middle Aged
• Ofloxacin (administration & dosage, adverse effects, therapeutic use)
• Skin Diseases (drug therapy)
• Ticarcillin (administration & dosage, adverse effects, therapeutic use)
• Treatment Outcome