Status:
COMPLETED
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
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Skin Diseases, Infectious
Cellulitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
Levofloxacin is an antibacterial agent used for the treatment of many types of infections in adults. This is a randomized, open-label, parallel group, multicenter study to determine the safety and eff...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 1991
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 1993
Estimated Enrollment :
431 Patients enrolled
Trial Details
Trial ID
NCT00257036
Start Date
July 1 1991
End Date
February 1 1993
Last Update
June 10 2011
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