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
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
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
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
result
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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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