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

This study has been terminated.
(This study was terminated due to low enrollment.)
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00236912
First received: October 7, 2005
Last updated: June 8, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Appendicitis
Drug: levofloxacin; metronidazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

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.

Enrollment: 139
Study Start Date: July 2003
Study Completion Date: September 2004
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236912

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PriCara, Unit of Ortho-McNeil, Inc.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00236912     History of Changes
Other Study ID Numbers: CR002656
Study First Received: October 7, 2005
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
complicated appendicitis
antibiotics
appendicitis
infection

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Piperacillin-tazobactam combination product
Metronidazole
Levofloxacin
Ofloxacin
Piperacillin
Penicillanic Acid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Anti-Infective Agents, Urinary
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014