Oral Moxifloxacin Versus Cefazolin and Oral Probenecid in the Management of Skin and Soft Tissue Infections in the Emergency Department
Information source: University of British Columbia
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cellulitis
Intervention: Cefazolin and Moxifloxacin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s):
Rob Stenstrom, MD, Principal Investigator, Affiliation: The University of British Columbia
Overall contact:
Barb Boychuk, Email: robstenstrom@shaw.ca
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.
Clinical Details
Official title: Oral Moxifloxacin Versus Cefazolin and Oral Probenecid in the Management of Skin and Soft Tissue Infections in the Emergency Department
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Clinical cure at 7 days
Secondary outcome: 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
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).
Eligibility
Minimum age: N/A.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Cellulitis requiring outpatient intravenous antibiotic therapy;
- ability to understand,/sign informed consent;
- no contraindications to study medications,
- not pregnant/breastfeeding
Exclusion Criteria:
-
Locations and Contacts
Barb Boychuk, Email: robstenstrom@shaw.ca
St. Paul's Hospital, Providence Healthcare, Emergency Medicine, Vancouver, British Columbia V1Y 1Z1, Canada; Recruiting
Barb Boychuk
Rob Stenstrom, MD, Principal Investigator
Additional Information
Starting date: January 2004
Ending date: December 2008
Last updated: September 23, 2008
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