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

NCT00323219 | Completed Phase 3

• 1 other identifier: H03-50153
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cellulitis

Keywords

Cellulitis, RCT, emergency Department, Double-blind, Equivalence trial, Moxifloxacin, Cefazolin, Probenecid.

Outcome Measures

Primary Outcomes (1)

• Clinical cure at 7 days

  7 days

Secondary Outcomes (1)

• 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

Study Arms (2)

study closed 2009

OTHER

Study is closed as of 2009

Drug: Cefazolin and Moxifloxacin

closed 2009

NO INTERVENTION

Interventions

Cefazolin and Moxifloxacin DRUG

study closed 2009

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital, Providence Healthcare, Emergency Medicine

Vancouver, British Columbia, V1Y 1Z1, Canada

Location

MeSH Terms

Conditions

Cellulitis; Emergencies

Interventions

Cefazolin; Moxifloxacin

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Rob Stenstrom, MD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2006
• First Posted: May 9, 2006
• Study Start: January 1, 2004
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: April 13, 2026

Record last verified: 2025-01

Locations

CA (1)