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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified February 2012 by University of British Columbia.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00323219

First Posted: May 9, 2006

Last Update Posted: February 8, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

University of British Columbia

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 3


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Cellulitis

Drug Information available for: Probenecid Cefazolin Cefazolin sodium Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]


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)

Intervention Details:

See Detailed Description.

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323219

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 History of Changes
Other Study ID Numbers:	PO3-0153
First Submitted:	May 8, 2006
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

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