NCT00236912

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2003

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
Last Updated

June 10, 2011

Status Verified

April 1, 2010

First QC Date

October 7, 2005

Last Update Submit

June 8, 2011

Conditions

Appendicitis

Keywords

complicated appendicitisantibioticsappendicitisinfection

Outcome Measures

Primary Outcomes (1)

  • Clinical success at the post-therapy visit; safety by adverse events.

Secondary Outcomes (1)

  • Clinical and microbiologic response at post-therapy and post-study; costs associated with care.

Interventions

levofloxacin; metronidazoleDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

AppendicitisInfections

Interventions

LevofloxacinMetronidazole

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

July 1, 2003

Study Completion

September 1, 2004

Last Updated

June 10, 2011

Record last verified: 2010-04