Status:

COMPLETED

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

Lead Sponsor:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Collaborating Sponsors:

PriCara, Unit of Ortho-McNeil, Inc.

Conditions:

Skin Diseases, Infectious

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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 inf...

Detailed Description

Levofloxacin is an antibacterial agent used for the treatment of many types of infections in adults. This is a randomized, double-blind, parallel group, multicenter study to determine the safety and e...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 1993

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 1994

Estimated Enrollment :

361 Patients enrolled

Trial Details

Trial ID

NCT00257062

Start Date

January 1 1993

End Date

April 1 1994

Last Update

June 10 2011

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