A Study Comparing Safety and Efficacy of Levofloxacin and Metronidazole Versus Piperacillin/Tazobactam in Treating Complicated Appendicitis
Primary Purpose
Appendicitis
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
levofloxacin; metronidazole
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis focused on measuring complicated appendicitis, antibiotics, appendicitis, infection
Eligibility Criteria
Inclusion Criteria: Two or more symptoms of acute appendicitis for at least 24 hours or radiologic evidence of complicated appendicitis Able to take medicine orally after recovering from surgery If female, using birth control Exclusion Criteria: History of allergy to any study medication Life expectancy < 72 hours APACHE II (health) score > 25 Neutropenic (low white blood cell count) HIV positive with current or past CD4 count < 200/mm^3 Low platelet count (bleeds easily) Malnourished with low albumin Condition requiring use of major tranquilizers
Sites / Locations
Outcomes
Primary Outcome Measures
Clinical success at the post-therapy visit; safety by adverse events.
Secondary Outcome Measures
Clinical and microbiologic response at post-therapy and post-study; costs associated with care.
Full Information
NCT ID
NCT00236912
First Posted
October 7, 2005
Last Updated
June 8, 2011
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
PriCara, Unit of Ortho-McNeil, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00236912
Brief Title
A Study Comparing Safety and Efficacy of Levofloxacin and Metronidazole Versus Piperacillin/Tazobactam in Treating Complicated Appendicitis
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 Piperacillin/Tazobactam in the Treatment of Complicated Appendicitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated due to low enrollment.
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
PriCara, Unit of Ortho-McNeil, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 levofloxacin/metronidazole versus piperacillin/tazobactam for 4 to 14 days. Patients may be switched to oral therapy after 48 hours, at the doctor's 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 levofloxacin/metronidazole IV group (given once daily) or the piperacillin/tazobactam 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 doctor's discretion. Patients randomized to levofloxacin/metronidazole will be switched to oral levofloxacin/metronidazole given once daily. Patients randomized to piperacillin/tazobactam will be switched to oral amoxicillin/clavulanate 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 piperacillin/tazobactam 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 piperacillin/tazobactam 3.375 grams IV every 6 hours (or amoxicillin/clavulanate acid 875/125 milligram tablets by mouth every 12 hours) for 4 to 14 days
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
complicated appendicitis, antibiotics, appendicitis, infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
levofloxacin; metronidazole
Primary Outcome Measure Information:
Title
Clinical success at the post-therapy visit; safety by adverse events.
Secondary Outcome Measure Information:
Title
Clinical and microbiologic response at post-therapy and post-study; costs associated with care.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Two or more symptoms of acute appendicitis for at least 24 hours or radiologic evidence of complicated appendicitis
Able to take medicine orally after recovering from surgery
If female, using birth control
Exclusion Criteria:
History of allergy to any study medication
Life expectancy < 72 hours
APACHE II (health) score > 25
Neutropenic (low white blood cell count)
HIV positive with current or past CD4 count < 200/mm^3
Low platelet count (bleeds easily)
Malnourished with low albumin
Condition requiring use of major tranquilizers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=484&filename=CR002656_CSR.pdf
Description
A Multicenter, Open-Label, Randomized Study to Compare the Safety and Efficacy of Once Daily Levofloxacin Along With Once Daily Metronidazole Versus Piperacillin/Tazobactam in the Treatment of Complicated Appendicitis
Learn more about this trial
A Study Comparing Safety and Efficacy of Levofloxacin and Metronidazole Versus Piperacillin/Tazobactam in Treating Complicated Appendicitis
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