Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236912
Status:
TERMINATED
Last Update Posted:
2011-06-10
First Post:
2005-10-07
Brief Title:
A Study Comparing Safety and Efficacy of Levofloxacin and Metronidazole Versus PiperacillinTazobactam in Treating Complicated Appendicitis
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Multi-center Open-label Randomized Study to Compare the Safety and Efficacy of Once Daily Levofloxacin Along With Once Daily Metronidazole Versus PiperacillinTazobactam in the Treatment of Complicated Appendicitis
Status:
TERMINATED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was terminated due to low enrollment
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 efficacy and safety of two treatment regimens in treating patients with complicated appendicitis Appendicitis requires antibiotic treatment when the appendix ruptures complicated appendicitis This is a study comparing intravenous IV antibiotic therapy of levofloxacinmetronidazole versus piperacillintazobactam for 4 to 14 days Patients may be switched to oral therapy after 48 hours at the doctors discretion
Detailed Description:
Appendicitis may be classified as uncomplicated the appendix has not ruptured or complicated the appendix has ruptured or gangrene has begun Typically all patients with complicated appendicitis are treated with intravenous IV through a vein antibiotic therapy This is a multicenter open-label randomized study of patients who have complicated appendicitis Prior to surgery patients will be randomized to either the levofloxacinmetronidazole IV group given once daily or the piperacillintazobactam IV group given 4 times daily and will be started on study drug Patients who are confirmed during surgery to have complicated appendicitis will continue to receive study drug to complete a total of 4-14 days of therapy Those found to have uncomplicated appendicitis will stop taking study drug and be discontinued from the study Patients may be switched after 48 hours to oral therapy at the doctors discretion Patients randomized to levofloxacinmetronidazole will be switched to oral levofloxacinmetronidazole given once daily Patients randomized to piperacillintazobactam will be switched to oral amoxicillinclavulanate acid given twice daily While in the hospital daily assessments will be made of the patient for clinical signs and symptoms of post-operative wound infection In addition temperature vital signs pertinent physical findings white blood count until normal and tests for infection will be assessed daily while in the hospital Wound assessments and laboratory tests will be performed on the last visit as an outpatient The main objective of this study is to determine the safety and effectiveness of the regimen containing levofloxacin and metronidazole compared with the regimen of piperacillintazobactam in the treatment of complicated appendicitis
Levofloxacin 750 mg IV through a vein or orally then metronidazole 1500 milligrams IV or tablet form by mouth once daily for 4 to 14 days or piperacillintazobactam 3375 grams IV every 6 hours or amoxicillinclavulanate acid 875125 milligram tablets by mouth every 12 hours for 4 to 14 days
Levofloxacin 750 mg IV through a vein or orally then metronidazole 1500 milligrams IV or tablet form by mouth once daily for 4 to 14 days or piperacillintazobactam 3375 grams IV every 6 hours or amoxicillinclavulanate acid 875125 milligram tablets by mouth every 12 hours for 4 to 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