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

NCT ID: NCT00323219

Last Updated: 2012-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2013-12-31

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 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).

Conditions

Cellulitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Cefazolin and Moxifloxacin

See Detailed Description.

Intervention Type: DRUG

Eligibility 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

-

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rob Stenstrom, MD

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia

Locations

St. Paul's Hospital, Providence Healthcare, Emergency Medicine

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Barb Boychuk

Role: CONTACT

robstenstrom@shaw.ca

Facility Contacts

Barb Boychuk

Role: primary

Other Identifiers

PO3-0153

Identifier Type: -

Identifier Source: org_study_id