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

This study has been completed.
Sponsor:
Information provided by:
Fraser Health
ClinicalTrials.gov Identifier:
NCT01037192
First received: December 18, 2009
Last updated: June 11, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Skin and Soft Tissue Infections
Drug: vancomycin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections

Resource links provided by NLM:


Further study details as provided by Fraser Health:

Primary Outcome Measures:
  • Clinical Efficacy [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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:
  • Microbiological Efficacy [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 4
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vanco once daily
Subject receives vancomycin 30 mg/kg dose
Drug: vancomycin
vancomycin 30 mg/kg intravenous administered once daily
Active Comparator: Vanco twice daily
Subject receives vancomycin 15 mg/kg twice daily
Drug: vancomycin
vancomycin 15 mg/kg intravenous administered twice daily (standard dosing)

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037192

Locations
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Sponsors and Collaborators
Fraser Health
Investigators
Principal Investigator: Anna Yuen, BSc. Pharm Fraser Health
  More Information

Publications:
Responsible Party: Anna Yuen, BSc. Pharm, ACPR, Fraser Health Authority
ClinicalTrials.gov Identifier: NCT01037192     History of Changes
Other Study ID Numbers: VOD
Study First Received: December 18, 2009
Results First Received: May 10, 2011
Last Updated: June 11, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Fraser Health:
outpatient
skin and soft tissue infections
vancomycin intravenous

Additional relevant MeSH terms:
Infection
Communicable Diseases
Soft Tissue Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014