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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2010

Interventions

  • Drug: vancomycin
    • vancomycin 30 mg/kg intravenous administered once daily
  • Drug: vancomycin
    • vancomycin 15 mg/kg intravenous administered twice daily (standard dosing)

Arms, Groups and Cohorts

  • Experimental: Vanco once daily
    • Subject receives vancomycin 30 mg/kg dose
  • Active Comparator: Vanco twice daily
    • Subject receives vancomycin 15 mg/kg twice daily

Clinical Trial Outcome Measures

Primary Measures

  • Clinical Efficacy
    • Time Frame: 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 Measures

  • Microbiological Efficacy
    • Time Frame: 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.

Participating in This Clinical Trial

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 (< 1×109/L)
  • Renal impairment (serum creatinine > 177 ┬Ámol/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)

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fraser Health
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anna Yuen, Pharmacist – Fraser Health
  • Overall Official(s)
    • Anna Yuen, BSc. Pharm, Principal Investigator, Fraser Health

Citations Reporting on Results

Cohen E, Dadashev A, Drucker M, Samra Z, Rubinstein E, Garty M. Once-daily versus twice-daily intravenous administration of vancomycin for infections in hospitalized patients. J Antimicrob Chemother. 2002 Jan;49(1):155-60.

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