Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections
Information source: Fraser Health
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Skin and Soft Tissue Infections
Intervention: vancomycin (Drug); vancomycin (Drug)
Phase: N/A
Status: Completed
Sponsored by: Fraser Health Official(s) and/or principal investigator(s): Anna Yuen, BSc. Pharm, Principal Investigator, Affiliation: Fraser Health
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.
Clinical Details
Official title: Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical Efficacy
Secondary outcome: Microbiological Efficacy
Eligibility
Minimum age: 19 Years.
Maximum age: 70 Years.
Gender(s): Both.
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 (< 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)
Locations and Contacts
Royal Columbian Hospital, New Westminster, British Columbia V3L 3W7, Canada
Additional Information
Starting date: March 2010
Last updated: June 11, 2011
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