Oral Moxifloxacin Versus Cefazolin and Oral Probenecid in the Management of Skin and Soft Tissue Infections in the Emergency Department

Patients often come to the emergency department with bacterial skin infections (known as "cellulitis"). Some patients with very severe infections are admitted to hospital for antibiotic treatment and some are sent home on oral antibiotics. Many patients have moderate infections and are treated as outpatients with daily intravenous antibiotics for 2-5 days. In this patient group it is unclear if treatment with oral antibiotics is as effective as intravenous antibiotics. The purpose of this study is to determine if treatment of moderate cellulitis with an intravenous antibiotic (cefazolin) for 3-5 days is as effective as treatment with an oral antibiotic (moxifloxacin). We hypothesize that the oral agent will be as effective as intravenous treatment for moderate cellulitis.

Study Overview

• Status: Unknown
• Conditions: Cellulitis
• Intervention / Treatment: Drug: Cefazolin and Moxifloxacin

Detailed Description

Extended description of the protocol, including information not already contained in other fields.

Objective: To compare 400 mg of oral moxifloxacin (Oral Group) once daily to 2 grams of IV cefazolin and 1 gram of oral probenecid once daily (IV group) for the treatment of moderate cellulitis.

Patients: Any patient presenting to the emergency department at St Paul's Hospital in Vancouver with a diagnosis of cellulitis requiring IV antibiotics, without contraindications to any of the study treatments, and not requiring hospital admission.

Assessments: Daily assessments are performed double-blind at 0, 1, 2, 3, 4, 5, 6, 7 and 14 days.

Primary outcome: Clinical cure at 7 days (resolution of symptoms, no change in antibiotic, no adverse events requiring discontinuation of study drug, no admission to hospital).

Secondary outcomes: Area of erythema, days of treatment, side-effects of medication, cost of treatment, patient satisfaction, relapse at 14 days.

Sample size: Based on equivalence of treatments a total of 390 patients are required (195/group).

• Study Type: Interventional
• Enrollment (Anticipated): 390
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Barb Boychuk; Email: robstenstrom@shaw.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V1Y 1Z1
      • Recruiting
      • St. Paul's Hospital, Providence Healthcare, Emergency Medicine
      • Contact: Barb Boychuk
      • Principal Investigator: Rob Stenstrom, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cellulitis requiring outpatient intravenous antibiotic therapy;
• ability to understand,/sign informed consent;
• no contraindications to study medications,
• not pregnant/breastfeeding

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical cure at 7 days	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Area of erythema (Days 0, 1, 2, 3, 4, 5, 6, 7), days of treatment, side-effects of medication, cost of treatment, patient satisfaction, relapse at 14 days	7 days

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Rob Stenstrom, MD, The University of British Columbia

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: May 8, 2006
• First Submitted That Met QC Criteria: May 8, 2006
• First Posted (Estimate): May 9, 2006

Study Record Updates

• Last Update Posted (Estimate): February 8, 2012
• Last Update Submitted That Met QC Criteria: February 6, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Cellulitis, RCT, emergency Department, Double-blind, Equivalence trial, Moxifloxacin, Cefazolin, Probenecid.
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Disease Attributes; Connective Tissue Diseases; Skin Diseases, Infectious; Suppuration; Emergencies; Cellulitis; Soft Tissue Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin; Cefazolin
• Other Study ID Numbers: PO3-0153