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

Study Description

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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

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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

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Intervention Details:

Drug: Cefazolin and Moxifloxacin
See Detailed Description.

Outcome Measures

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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

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00323219 History of Changes
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:

Emergencies; Soft Tissue Infections; Cellulitis; Disease Attributes; Pathologic Processes; Infection; Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Inflammation; Moxifloxacin; Fluoroquinolones; Cefazolin; Norgestimate, ethinyl estradiol drug combination; Probenecid

Anti-Bacterial Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Nucleic Acid Synthesis Inhibitors; Uricosuric Agents