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

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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Skin and Soft Tissue Infections
Intervention Drug: vancomycin
Enrollment 4
Recruitment Details Subjects were recruited from March to September 2010 from patients from the Outpatient Antibiotic Intravenous Therapy clinic at the Royal Columbian Hospital, New Westminster, BC, Canada.
Pre-assignment Details Subjects were excluded from the trial based on the inclusion and exclusion criteria. The main reasons for exclusion include age and weight.
Arm/Group Title Vancomycin Once Daily Vancomycin Twice Daily
Hide Arm/Group Description Subject receives vancomycin 30 mg/kg dose Subject receives vancomycin 15 mg/kg twice daily
Period Title: Overall Study
Started 3 1
Completed 3 1
Not Completed 0 0
Arm/Group Title Vancomycin Once Daily Vancomycin Twice Daily Total
Hide Arm/Group Description Subject receives vancomycin 30 mg/kg dose Subject receives vancomycin 15 mg/kg twice daily Total of all reporting groups
Overall Number of Baseline Participants 3 1 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
1
 100.0%
4
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 1 participants 4 participants
48  (12) 49 48  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 4 participants
Female
1
  33.3%
0
   0.0%
1
  25.0%
Male
2
  66.7%
1
 100.0%
3
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 3 participants 1 participants 4 participants
3 1 4
1.Primary Outcome
Title Clinical Efficacy
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vancomycin Once Daily Vancomycin Twice Daily
Hide Arm/Group Description:
Vancomycin 30 mg/kg IV daily
Vancomycin 15 mg/kg IV twice daily
Overall Number of Participants Analyzed 3 1
Overall Number of Units Analyzed
Type of Units Analyzed: Subjects
3 1
Measure Type: Number
Unit of Measure: participants
2 0
2.Secondary Outcome
Title Microbiological Efficacy
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vancomycin Once Daily Vancomycin Twice Daily
Hide Arm/Group Description:
Subject receives vancomycin 30 mg/kg dose
Subject receives vancomycin 15 mg/kg twice daily
Overall Number of Participants Analyzed 3 1
Measure Type: Number
Unit of Measure: participants
Favourable 0 0
Unfavourable 1 0
Indeterminate 2 1
Time Frame 6 months
Adverse Event Reporting Description March 1 to September 30, 2010
 
Arm/Group Title Vancomycin Once Daily Vancomycin Twice Daily
Hide Arm/Group Description Subject receives vancomycin 30 mg/kg dose Subject receives vancomycin 15 mg/kg twice daily
All-Cause Mortality
Vancomycin Once Daily Vancomycin Twice Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vancomycin Once Daily Vancomycin Twice Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vancomycin Once Daily Vancomycin Twice Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
The main limitation was low enrollment, primarily caused by stringent inclusion criteria. The age limitation was required to ensure safe vancomycin administration. The weight limitation was required for medication preparation.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anna Yuen, BSc. Pharm
Organization: Fraser Health Authority
Phone: 604-520-4005
EMail: anna.yuen@fraserhealth.ca
Layout table for additonal information
Responsible Party: Anna Yuen, Fraser Health
ClinicalTrials.gov Identifier: NCT01037192     History of Changes
Other Study ID Numbers: VOD
First Submitted: December 18, 2009
First Posted: December 22, 2009
Results First Submitted: May 10, 2011
Results First Posted: July 8, 2011
Last Update Posted: August 27, 2015