- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00257062
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
June 8, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
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.
Study Overview
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 effectiveness of levofloxacin (500 mg once daily for 7 days) compared with ciprofloxacin (500 mg once every 12 hours for 10 days) in adults with uncomplicated infections of the skin and the supportive layers beneath the skin.
The study consists of 3 visits: one visit for screening and enrollment, and 2 visits for assessment of safety and effectiveness (one visit 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 (categorized at post-therapy as cured, improved, or failed) and the microbiological response at post-therapy (the elimination of the disease-causing bacteria, categorized as eradicated, partially eradication, or persisted, determined by patient and by type of bacteria).
Safety evaluations (incidence of adverse events, physical examination, 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 uncomplicated infections of the skin and the supportive layers beneath the skin.
One levofloxacin 500 mg tablet by mouth, once daily (and a placebo tablet once daily, 12 hours later) for 7 days, followed by one placebo tablet every 12 hours for 3 days; or one ciprofloxacin 500 mg tablet by mouth once every 12 hours for 10 days.
Study Type
Interventional
Enrollment (Actual)
361
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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 Outcome Measures
Outcome Measure |
---|
Changes in physical examination and laboratory tests after treatment with the study drug
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1993
Study Completion (Actual)
April 1, 1994
Study Registration Dates
First Submitted
November 18, 2005
First Submitted That Met QC Criteria
November 18, 2005
First Posted (Estimate)
November 22, 2005
Study Record Updates
Last Update Posted (Estimate)
June 10, 2011
Last Update Submitted That Met QC Criteria
June 8, 2011
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Infections
- Communicable Diseases
- Skin Diseases, Infectious
- Skin Diseases
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Anti-Infective Agents, Urinary
- Renal Agents
- Levofloxacin
- Ofloxacin
Other Study ID Numbers
- CR005479
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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