Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257036
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-11-18
Brief Title:
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
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None