Trial record 9 of 13 for:    Open Studies | "Cellulitis"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of British Columbia.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
University of British Columbia Identifier:
First received: May 8, 2006
Last updated: February 6, 2012
Last verified: February 2012
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.

Condition Intervention Phase
Drug: Cefazolin and Moxifloxacin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Oral Moxifloxacin Versus Cefazolin and Oral Probenecid in the Management of Skin and Soft Tissue Infections in the Emergency Department

Resource links provided by NLM:

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Clinical cure at 7 days [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 390
Study Start Date: January 2004
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cefazolin and Moxifloxacin
    See Detailed Description.
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).


Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00323219

Contact: Barb Boychuk

Canada, British Columbia
St. Paul's Hospital, Providence Healthcare, Emergency Medicine Recruiting
Vancouver, British Columbia, Canada, V1Y 1Z1
Contact: Barb Boychuk         
Principal Investigator: Rob Stenstrom, MD         
Sponsors and Collaborators
University of British Columbia
Principal Investigator: Rob Stenstrom, MD The University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia Identifier: NCT00323219     History of Changes
Other Study ID Numbers: PO3-0153 
Study First Received: May 8, 2006
Last Updated: February 6, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Cellulitis, RCT, emergency Department, Double-blind, Equivalence trial, Moxifloxacin, Cefazolin, Probenecid.

Additional relevant MeSH terms:
Soft Tissue Infections
Connective Tissue Diseases
Disease Attributes
Pathologic Processes
Skin Diseases, Infectious
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Antirheumatic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Renal Agents
Reproductive Control Agents
Therapeutic Uses processed this record on February 04, 2016