Oral Moxifloxacin Versus Cefazolin and Oral Probenecid in the Management of Skin and Soft Tissue Infections in the Emergency Department
Recruitment status was: Recruiting
|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|
- Clinical cure at 7 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 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
|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)|
Drug: Cefazolin and Moxifloxacin
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323219
|Canada, British Columbia|
|St. Paul's Hospital, Providence Healthcare, Emergency Medicine|
|Vancouver, British Columbia, Canada, V1Y 1Z1|
|Principal Investigator:||Rob Stenstrom, MD||The University of British Columbia|