Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249197
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-11-04
Brief Title:
A Study of the Safety and Effectiveness of Levofloxacin Compared to TicarcillinClavulanate Alone or Followed by AmoxicillinClavulanate in the Treatment of Complicated Skin Infections
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Multicenter Randomized Open-Label Study to Compare the Safety and Efficacy of iv AndOr Oral Levofloxacin With That of TicarcillinClavulanate Alone or Followed by AmoxicillinClavulanate in the Treatment of Complicated Bacterial Skin and Skin Structure Infections
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 compare the safety and effectiveness of levofloxacin an antibiotic with ticarcillinclavulanate alone or followed by amoxicillinclavulanate in the treatment of complicated skin infections
Detailed Description:
Levofloxacin is an antibiotic that has been evaluated in clinical trials for use in the treatment of many types of infections including respiratory tract urinary tract and uncomplicated skin infections Levofloxacin may be taken by mouth or administered slowly through a vein and has been shown to be safe and effective when administered once daily This multicenter open-label study will evaluate the safety and effectiveness of a single daily oral or intravenous dose of levofloxacin compared to multiple daily intravenous doses with another antibiotic ticarcillinclavulanate given alone or followed by oral amoxicillinclavulanate in the treatment of bacterial skin infections Patients will receive 750 mg of levofloxacin by mouth or intravenously for 7 - 14 days or 31 grams of ticarcillinclavulanate intravenously for 7 - 14 days Patients receiving levofloxacin intravenously may be switched to receive levofloxacin by mouth patients receiving ticarcillinclavulanate intravenously may be switched to 875 mg of amoxicillinclavulanate given by mouth twice daily if significant improvement is noted Patients are assessed after 3 - 4 days of treatment treatment is discontinued if no significant improvement is noted Patients showing signs of improvement continue in the study with assessments 2 - 5 days post-therapy visit and 3 - 4 weeks post-study visit after completion of the study drug The primary measure of effectiveness is the clinical response rate assessed 2 - 5 days after the last dose of antibiotic treatment categorizing the response as cured improved or failed Laboratory tests for the presence of bacteria are performed throughout the study Safety evaluations incidence of adverse events physical examinations laboratory tests are performed throughout the study The study hypothesis is that a single daily dose of levofloxacin is at least as effective as multiple daily doses of ticarcillinclavulanate alone or followed by amoxicillinclavulanate in the treatment of skin infections and that it is well tolerated Levofloxacin 750 mg intravenously or by mouth once daily for 7 - 14 days or ticarcillinclavulanate 31 grams intravenously every 4 - 6 hours may be switched to amoxicillinclavulanate 875 mg by mouth twice daily total duration 7 - 14 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