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
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00323219
First received: May 8, 2006
Last updated: February 6, 2012
Last verified: February 2012

May 8, 2006
February 6, 2012
January 2004
December 2012   (final data collection date for primary outcome measure)
Clinical cure at 7 days [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Clinical cure at 7 days
Complete list of historical versions of study NCT00323219 on ClinicalTrials.gov Archive Site
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 ]
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
Not Provided
Not Provided
 
Oral Moxifloxacin Versus Cefazolin and Oral Probenecid in the Management of Skin and Soft Tissue Infections in the Emergency Department
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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cellulitis
Drug: Cefazolin and Moxifloxacin
See Detailed Description.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
390
December 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

-

Both
up to 18 Years
Yes
Contact: Barb Boychuk robstenstrom@shaw.ca
Canada
 
NCT00323219
PO3-0153
No
University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Rob Stenstrom, MD The University of British Columbia
University of British Columbia
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP