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 because the information has not been verified recently.

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

Sponsor:

Information provided by (Responsible Party):

University of British Columbia

ClinicalTrials.gov Identifier:

NCT00323219

First received: May 8, 2006

Last updated: February 6, 2012

Last verified: February 2012

History of Changes

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 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

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]


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


Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided


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

Keywords provided by University of British Columbia:


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

Additional relevant MeSH terms:


Cellulitis Emergencies Soft Tissue Infections Connective Tissue Diseases Disease Attributes Infection Inflammation Pathologic Processes Skin Diseases, Infectious Suppuration Cefazolin Moxifloxacin Norgestimate, ethinyl estradiol drug combination Probenecid Anti-Bacterial Agents	Anti-Infective Agents Antineoplastic Agents Antirheumatic Agents Contraceptive Agents Contraceptive Agents, Female Contraceptives, Oral Contraceptives, Oral, Combined Enzyme Inhibitors Gout Suppressants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Renal Agents Reproductive Control Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 26, 2015

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