A Study Comparing Safety and Efficacy of Levofloxacin and Metronidazole Versus Piperacillin/Tazobactam in Treating Complicated Appendicitis

• Status: Terminated
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PriCara, Unit of Ortho-McNeil, Inc.
• Treatments: Levofloxacin; Metronidazole; Ofloxacin; Penicillanic Acid; Piperacillin; Piperacillin, tazobactam drug combination; Tazobactam

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