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

Primary Purpose

Skin and Soft Tissue Infections

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
vancomycin
vancomycin
Sponsored by
Fraser Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin and Soft Tissue Infections focused on measuring outpatient, skin and soft tissue infections, vancomycin intravenous

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Royal Columbian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vanco once daily

Vanco twice daily

Arm Description

Subject receives vancomycin 30 mg/kg dose

Subject receives vancomycin 15 mg/kg twice daily

Outcomes

Primary Outcome Measures

Clinical Efficacy
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
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.

Full Information

First Posted
December 18, 2009
Last Updated
August 18, 2015
Sponsor
Fraser Health
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1. Study Identification

Unique Protocol Identification Number
NCT01037192
Brief Title
Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections
Acronym
VOD
Official Title
Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fraser Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin and Soft Tissue Infections
Keywords
outpatient, skin and soft tissue infections, vancomycin intravenous

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vanco once daily
Arm Type
Experimental
Arm Description
Subject receives vancomycin 30 mg/kg dose
Arm Title
Vanco twice daily
Arm Type
Active Comparator
Arm Description
Subject receives vancomycin 15 mg/kg twice daily
Intervention Type
Drug
Intervention Name(s)
vancomycin
Intervention Description
vancomycin 30 mg/kg intravenous administered once daily
Intervention Type
Drug
Intervention Name(s)
vancomycin
Intervention Description
vancomycin 15 mg/kg intravenous administered twice daily (standard dosing)
Primary Outcome Measure Information:
Title
Clinical Efficacy
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Microbiological Efficacy
Description
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.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 (< 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Yuen, BSc. Pharm
Organizational Affiliation
Fraser Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
11751780
Citation
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. doi: 10.1093/jac/49.1.155.
Results Reference
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Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections

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