Oral Moxifloxacin Versus Cefazolin and Oral Probenecid in the Management of Skin and Soft Tissue Infections in the Emergency Department
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|ClinicalTrials.gov Identifier: NCT00323219|
Recruitment Status : Unknown
Verified February 2012 by University of British Columbia.
Recruitment status was: Recruiting
First Posted : May 9, 2006
Last Update Posted : February 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cellulitis||Drug: Cefazolin and Moxifloxacin||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||390 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Drug: Cefazolin and Moxifloxacin
- Clinical cure at 7 days [ Time Frame: 7 days ]
- 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 ]
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
|Contact: Barb Boychukfirstname.lastname@example.org|
|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|
|Principal Investigator:||Rob Stenstrom, MD||The University of British Columbia|