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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
This study has been completed.
First Received: November 18, 2005   Last Updated: May 11, 2007   History of Changes
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator: PriCara, Unit of Ortho-McNeil, Inc.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00257036
  Purpose

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.


Condition Intervention Phase
Skin Diseases, Infectious
Cellulitis
Drug: levofloxacin
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Active-Controlled, Randomized Study to Evaluate the Safety and Efficacy of Levofloxacin Versus Ciprofloxacin HCl in the Treatment of Mild to Moderate Skin and Skin Structure Infections in Adults

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Clinical response rate (defined as cured, improved or failed) 2 - 7 days after the last dose of the study drug; rate of elimination of disease-causing bacteria (by patient, and by type of bacteria); incidence of adverse events.

Secondary Outcome Measures:
  • Change in physical examination and in laboratory tests after treatment with the study drug.

Estimated Enrollment: 440
Study Start Date: May 1991
Estimated Study Completion Date: February 1993
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 effectiveness of levofloxacin (500 mg by mouth once daily for 7-10 days) compared with another frequently used antibiotic, ciprofloxacin (500 mg by mouth every 12 hours for 7 -10 days), in adults with mild to moderate infections of the skin and the supportive layers beneath the skin. The study consists of 3 visits: one visit [pre-therapy] for screening and enrollment, and two visits to assess safety and effectiveness (one visit [on-therapy] on Days 3 - 5 of the study and one visit [post-therapy] 2 - 7 days after the last dose of the study drug). The total duration of patient participation in the study is approximately 2 weeks. The primary assessments of effectiveness include the clinical response to treatment (defined at post-therapy as cured, improved or failed) and the microbiological response at post-therapy (the rate of eradication of the disease-causing bacteria, determined by patient and by type of bacteria). Safety evaluations (incidence of adverse events, physical examination, physical examination of the skin, and laboratory tests) are performed throughout the study. The study hypothesis is that treatment with levofloxacin is at least as effective and as well tolerated as treatment with ciprofloxacin in patients with mild to moderate infections of the skin and the supportive layers beneath the skin.

Levofloxacin 500 mg by mouth once daily, or ciprofloxacin 500 mg by mouth every 12 hours. The duration of treatment is 7 to 10 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257036

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PriCara, Unit of Ortho-McNeil, Inc.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

Study ID Numbers: CR005476
Study First Received: November 18, 2005
Last Updated: May 11, 2007
ClinicalTrials.gov Identifier: NCT00257036     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Infectious skin diseases
bacterial skin diseases
cellulitis
levofloxacin
skin diseases
quinolones

Additional relevant MeSH terms:
Anti-Infective Agents
Communicable Diseases
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Ofloxacin
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Renal Agents
Infection
Pharmacologic Actions
Inflammation
Anti-Bacterial Agents
Ciprofloxacin
Cellulitis
Skin Diseases, Infectious
Pathologic Processes
Therapeutic Uses
Connective Tissue Diseases
Suppuration
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010