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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01037192
Recruitment Status : Completed
First Posted : December 22, 2009
Results First Posted : July 8, 2011
Last Update Posted : August 27, 2015
Sponsor:
Information provided by (Responsible Party):
Anna Yuen, Fraser Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Skin and Soft Tissue Infections Drug: vancomycin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections
Study Start Date : March 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

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Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037192


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

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Responsible Party: Anna Yuen, Pharmacist, Fraser Health
ClinicalTrials.gov Identifier: NCT01037192    
Other Study ID Numbers: VOD
First Posted: December 22, 2009    Key Record Dates
Results First Posted: July 8, 2011
Last Update Posted: August 27, 2015
Last Verified: August 2015
Keywords provided by Anna Yuen, Fraser Health:
outpatient
skin and soft tissue infections
vancomycin intravenous
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Soft Tissue Infections
Disease Attributes
 Pathologic Processes
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents