N/A N=4 Randomized Treatment

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

Skin and Soft Tissue Infections

Bottom Line

View on ClinicalTrials.gov: NCT01037192 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2011

Primary outcome: Primary: Clinical Efficacy — 2; 0 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: vancomycin (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Fraser Health
Primary completion: Sep 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Efficacy	2; 0	—
SECONDARY Microbiological Efficacy	0; 0; 1; 0; 2; 1	—

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.

Eligibility Criteria

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 ( 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01037192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.