Oral Moxifloxacin Versus Cefazolin and Oral Probenecid in the Management of Skin and Soft Tissue Infections in the Emergency Department

• ClinicalTrials.gov Identifier: NCT00323219
• Recruitment Status: Unknown
• First Posted: May 9, 2006
• Last Update Posted: February 8, 2012
• Sponsor: University of British Columbia
• Information provided by (Responsible Party): University of British Columbia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cellulitis	Drug: Cefazolin and Moxifloxacin	Phase 3

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 390 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: January 2004
• Estimated Primary Completion Date: December 2012
• Estimated Study Completion Date: December 2013

Arms and Interventions

Intervention Details:

• Drug: Cefazolin and Moxifloxacin
  See Detailed Description.

Outcome Measures

Primary Outcome Measures :

1. Clinical cure at 7 days [ Time Frame: 7 days ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: up to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

-

Contacts and Locations

Contacts

Contact: Barb Boychuk; robstenstrom@shaw.ca

Locations

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

Sponsors and Collaborators

University of British Columbia

Investigators

• Principal Investigator: Rob Stenstrom, MD; The University of British Columbia

More Information

• Responsible Party: University of British Columbia
• ClinicalTrials.gov Identifier: NCT00323219
• Other Study ID Numbers: PO3-0153
• First Posted: May 9, 2006
• Last Update Posted: February 8, 2012
• Last Verified: February 2012

Keywords provided by University of British Columbia:

Cellulitis, RCT, emergency Department, Double-blind, Equivalence trial, Moxifloxacin, Cefazolin, Probenecid.

Additional relevant MeSH terms:

Cellulitis; Soft Tissue Infections; Emergencies; Infection; Disease Attributes; Pathologic Processes; Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Inflammation; Moxifloxacin; Cefazolin; Anti-Bacterial Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents