Status:
TERMINATED
A Study Comparing Safety and Efficacy of Levofloxacin and Metronidazole Versus Piperacillin/Tazobactam in Treating Complicated Appendicitis
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Appendicitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 append...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT00236912
Start Date
July 1 2003
End Date
September 1 2004
Last Update
June 10 2011
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