Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323219
Status:
UNKNOWN
Last Update Posted:
2012-02-08
First Post:
2006-05-08
Brief Title:
Oral Moxifloxacin Versus Cefazolin and Oral Probenecid in the Management of Skin and Soft Tissue Infections in the Emergency Department
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Oral Moxifloxacin Versus Cefazolin and Oral Probenecid in the Management of Skin and Soft Tissue Infections in the Emergency Department
Status:
UNKNOWN
Status Verified Date:
2012-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Pauls 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 195group
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 Pauls 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 195group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None