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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00257062
Recruitment Status : Completed
First Posted : November 22, 2005
Last Update Posted : June 10, 2011
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE November 18, 2005
First Posted Date  ICMJE November 22, 2005
Last Update Posted Date June 10, 2011
Study Start Date  ICMJE January 1993
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2005)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2005)
Changes in physical examination and laboratory tests after treatment with the study drug
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Skin Diseases, Infectious
Intervention  ICMJE Drug: Levofloxacin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2009)
361
Original Enrollment  ICMJE
 (submitted: November 18, 2005)
400
Actual Study Completion Date  ICMJE April 1994
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00257062
Other Study ID Numbers  ICMJE CR005479
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE PriCara, Unit of Ortho-McNeil, Inc.
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP