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| Sponsor: | University of British Columbia |
|---|---|
| Information provided by (Responsible Party): | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00323219 |
Purpose
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 |
|---|---|---|
|
Cellulitis |
Drug: Cefazolin and Moxifloxacin |
Phase III |
| 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 |
| 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) |
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| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
-
Contacts and Locations| Contact: Barb Boychuk | robstenstrom@shaw.ca |
| 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 | |
| Principal Investigator: | Rob Stenstrom, MD | The University of British Columbia |
More Information
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov 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 |
|
Cellulitis, RCT, emergency Department, Double-blind, Equivalence trial, Moxifloxacin, Cefazolin, Probenecid. |
|
Cellulitis Emergencies Soft Tissue Infections Skin Diseases, Infectious Infection Suppuration Connective Tissue Diseases Inflammation Pathologic Processes Disease Attributes Cefazolin Moxifloxacin Probenecid Norgestimate, ethinyl estradiol drug combination |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Uricosuric Agents Gout Suppressants Antirheumatic Agents Renal Agents Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
