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

• Status: Completed
• Trial end date: 1993-02-01
• 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 ciprofloxacin, another antibiotic, in the treatment of adults with mild to moderate infections of the skin and the supportive layers beneath the skin.

• Phase: Phase 2/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 mild to moderate infection of the skin and/or the supportive layers beneath the skin, as indicated by pain at the site of the infection, redness, drainage, swelling, or other relevant clinical signs

• tissue sample available from the area of the skin affected by the bacteria

• able to take medication by mouth

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 reactions to similar antibiotics

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

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