A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Adults With Uncomplicated Infections of the Skin and the Supportive Layers Beneath the Skin

• Status: Completed
• Trial end date: 1994-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with another antibiotic, ciprofloxacin, in the treatment of adults with uncomplicated infections of the skin and the supportive layers beneath the skin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PriCara, Unit of Ortho-McNeil, Inc.
• Treatments: Ciprofloxacin; Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

• Diagnosis of infection of the skin and/or the supportive layers beneath the skin, as indicated by pain at the site of the infection, redness, swelling, drainage, or other relevant clinical signs

• able to provide a sample of tissue from the affected area of the skin

• able to receive oral medications.

Exclusion Criteria:

• Patients with a condition requiring treatment with antibiotics by injection into a vein, a muscle, or beneath the skin

• having a severe infection

• previous allergic or serious adverse reaction to similar antibiotics, or have severe lactose intolerance

• taken antibiotics internally within 48 hours of the start of the study with resulting improvement

• requirement of a second antibiotic taken internally or requirement of an antibiotic applied directly to the site of the infection in addition to the study drug