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

NCT00257036 | Completed Phase 2

• 1 other identifier: CR005476
• Study Type: interventional
• Target: 431
• Locations: 0 countries
• Sites: N/A

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 infections of the skin and the supportive layers beneath the skin.

Conditions

Skin Diseases, Infectious; Cellulitis

Keywords

Infectious skin diseases; skin diseases; bacterial skin diseases; cellulitis; quinolones; levofloxacin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in physical examination and in laboratory tests after treatment with the study drug.

Interventions

levofloxacin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• PriCara, Unit of Ortho-McNeil, Inc.: collaborator

Related Links

• 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

MeSH Terms

Conditions

Skin Diseases, Infectious; Cellulitis; Skin Diseases; Skin Diseases, Bacterial

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Infections; Skin and Connective Tissue Diseases; Suppuration; Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 18, 2005
• First Posted: November 22, 2005
• Study Start: July 1, 1991
• Study Completion: February 1, 1993
• Last Updated: June 10, 2011

Record last verified: 2011-01