Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections

Not Applicable

Completed

• Conditions: Skin and Soft Tissue Infections
• Interventions: Drug: vancomycin

• Registration Number: NCT01037192
• Lead Sponsor: Fraser Health

Brief Summary

Our hypothesis is that large-dose, extended-interval vancomycin (30 mg/kg IV q24h) administration provides non-inferior clinical efficacy and microbiological efficacy to standard vancomycin (15 mg/kg IV q12h) administration for skin and soft tissue infections in an outpatient setting.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-18
• Study First Submitted QC: 2009-12-18
• Study First Posted: 2009-12-22
• Study Start: 2010-03
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Results First Submitted: 2011-05-10
• Results First Submitted QC: 2011-06-11
• Results First Posted: 2011-07-08
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Age 19 to 70 years
• Weight 40 - 80 kg
• Suspected or confirmed skin or soft tissue infection for which vancomycin is indicated
• Subject referred to or admitted into OPAT by an Infectious Disease Specialist or Emergency Physician
• Subject able to provide informed consent

Exclusion Criteria

• Known history of allergy to vancomycin
• Pregnancy
• Granulocytopenia (< 1x109/L)
• Renal impairment (serum creatinine > 177 µmol/L or eGFR < 50 mL/min)
• Known history of vestibular disease or hearing loss
• Subjects treated with vancomycin within the previous month
• Subjects who have received more than 24 hours of vancomycin
• Subjects receiving other antimicrobials that cover MRSA (e.g. cotrimoxazole, rifampin, linezolid)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vanco once daily	vancomycin	Subject receives vancomycin 30 mg/kg dose
Vanco twice daily	vancomycin	Subject receives vancomycin 15 mg/kg twice daily

Primary Outcome Measures

Name	Time	Method
Clinical Efficacy	5 days	Clinical efficacy is determined on the fifth and last day of therapy and is defined favourable if there is resolution of symptoms of infection, return to normal body temperature for at least 48 hours, and normalization or a decrease (\> 15%) in leukocytes.

Secondary Outcome Measures

Name	Time	Method
Microbiological Efficacy	5 days	Microbiological efficacy is defined as favourable if a repeat culture is negative, if no more materail was obtainable for culture, or if a new microorganism is cultured without clinical signs of infection. It is defined as unfavourable when repeat cultures are positive for the same microorganism, when a new microorganism is cultured with clinical signs of infection or when vancomycin resistance develops. It is defined as indeterminate when the patient is treated with another antibiotic to which the microorganism is susceptible or when no microorganism was cultured at the start of therapy.

Trial Locations

Locations (1)

Royal Columbian Hospital; 🇨🇦 New Westminster, British Columbia, Canada