- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01037192
Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections (VOD)
August 18, 2015 updated by: Anna Yuen, Fraser Health
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
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New Westminster, British Columbia, Canada, V3L 3W7
- Royal Columbian Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vanco once daily
Subject receives vancomycin 30 mg/kg dose
|
vancomycin 30 mg/kg intravenous administered once daily
vancomycin 15 mg/kg intravenous administered twice daily (standard dosing)
|
Active Comparator: Vanco twice daily
Subject receives vancomycin 15 mg/kg twice daily
|
vancomycin 30 mg/kg intravenous administered once daily
vancomycin 15 mg/kg intravenous administered twice daily (standard dosing)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anna Yuen, BSc. Pharm, Fraser Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
December 18, 2009
First Submitted That Met QC Criteria
December 18, 2009
First Posted (Estimate)
December 22, 2009
Study Record Updates
Last Update Posted (Estimate)
August 27, 2015
Last Update Submitted That Met QC Criteria
August 18, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VOD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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PfizerCompletedIntra-Abdominal Infections | Skin Disease, Infectious | Soft Tissues Infections
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-
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