Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257049
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-11-18
Brief Title:
A Study of the Safety and Effectiveness of Levofloxacin Compared With Ceftriaxone Sodium or Cefuroxime Axetil in the Treatment of Adults With Pneumonia
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 Ceftriaxone Sodium Or Cefuroxime Axetil In The Treatment Of Community-Acquired Pneumonia In Adults
Status:
COMPLETED
Status Verified Date:
2010-11
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 evaluation of the safety and effectiveness of levofloxacin an antibiotic compared with ceftriaxone sodium or cefuroxime axetil in the treatment of adults with pneumonia
Detailed Description:
This is a randomized open-label parallel group multicenter study to determine the safety and effectiveness of levofloxacin 488 mg once daily by mouth or 500 mg administered intravenously once daily for 7 - 14 days compared with ceftriaxone sodium 1 - 2 grams administered into a vein or muscle once daily or in divided doses twice daily for 7 - 14 days or cefuroxime axetil 500 mg by mouth twice daily for 7 - 14 days in adults with community-acquired pneumonia The study consists of 4 visits one visit for screening and enrollment and 3 visits for assessment of safety and effectiveness one visit on Day 2 - 4 on-therapy one visit post-therapy 5 - 7 days after the last dose of the study drug and one visit post-study 21 - 28 days after the last dose of the study drug The total duration of patient participation in the study is approximately 6 weeks Levofloxacin is an antibacterial agent used for the treatment of many types of infections in adults The purpose of this study is to compare the safety and effectiveness of levofloxacin with other frequently used antibiotics ceftriaxone sodium or cefuroxime axetil in the treatment of adults with pneumonia acquired in the community The primary efficacy assessment is the clinical response 5 - 7 days after the last dose of study drug categorized as cured improved or failed based upon changes in signs and symptoms and changes in x-ray findings Safety evaluations incidence of adverse events physical examination and laboratory tests are performed throughout the study Cost-effectiveness is also assessed for the study drugs The study hypothesis is that treatment with levofloxacin will be at least as effective as ceftriaxone sodium or cefuroxime axetil in treating patients with pneumonia acquired in the community and that it will be well tolerated Levofloxacin 488 mg by mouth once daily or 500 mg intravenously once daily ceftriaxone sodium 1 - 2 grams administered into a vein or muscle once daily or in divided doses twice daily or cefuroxime axetil 500 mg by mouth twice daily Treatment duration is 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