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
A Multicenter, Double-Blind, Randomized Study to Compare the Safety and Efficacy of Oral Levofloxacin With That of Ciprofloxacin HCl in the Treatment of Uncomplicated Skin and Skin Structure Infections in Adults
1 other identifier
interventional
361
0 countries
N/A
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 infections of the skin and the supportive layers beneath the skin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 1993
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1993
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 1994
CompletedFirst Submitted
Initial submission to the registry
November 18, 2005
CompletedFirst Posted
Study publicly available on registry
November 22, 2005
CompletedJune 10, 2011
April 1, 2010
November 18, 2005
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical response rate at post-therapy (defined as cured, improved or failed); microbiological response at post-therapy (rate of elimination of disease-causing bacteria, by patient, and by type of bacteria); incidence of adverse events
Secondary Outcomes (1)
Changes in physical examination and laboratory tests after treatment with the study drug
Interventions
Eligibility Criteria
You may qualify if:
- 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.
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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 18, 2005
First Posted
November 22, 2005
Study Start
January 1, 1993
Study Completion
April 1, 1994
Last Updated
June 10, 2011
Record last verified: 2010-04