A Study of the Safety and Effectiveness of Levofloxacin Compared to Ticarcillin/Clavulanate Alone or Followed by Amoxicillin/Clavulanate in the Treatment of Complicated Skin Infections

Phase 3 Completed 413 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PriCara, Unit of Ortho-McNeil, Inc. · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the safety and effectiveness of levofloxacin (an antibiotic) with ticarcillin/clavulanate alone or followed by amoxicillin/clavulanate in the treatment of complicated skin infections.

Timeline

Start: 1997-01
Primary completion: —
Completion: 1998-07

Outcome

Met primary endpoint

paper In the clinically evaluable population, therapeutic equivalence was demonstrated between the levofloxacin and TC/AC regimens PMID 12145720 ↗

Publications

Results Graham DR, Talan DA, Nichols RL, Lucasti C, Corrado M, Morgan N, Fowler CL. 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. Clin Infect Dis. 2002 Aug 15;35(4):381-9. doi: 10.1086/341026. Epub 2002 Jul 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levofloxacin	Small molecule	750 mg	Oral