Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vanco once daily | Experimental | Subject receives vancomycin 30 mg/kg dose |
|
| Vanco twice daily | Active Comparator | Subject receives vancomycin 15 mg/kg twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vancomycin | Drug | vancomycin 30 mg/kg intravenous administered once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anna Yuen, BSc. Pharm | Fraser Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Columbian Hospital | New Westminster | British Columbia | V3L 3W7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11751780 | Result | 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. |
Not provided
Not provided
Subjects were excluded from the trial based on the inclusion and exclusion criteria. The main reasons for exclusion include age and weight.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vancomycin Once Daily | Subject receives vancomycin 30 mg/kg dose |
| FG001 | Vancomycin Twice Daily | Subject receives vancomycin 15 mg/kg twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vancomycin Once Daily | Subject receives vancomycin 30 mg/kg dose |
| BG001 | Vancomycin Twice Daily | Subject receives vancomycin 15 mg/kg twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 5 days | subjects | Participants |
|
6 months
March 1 to September 30, 2010
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vancomycin Once Daily | Subject receives vancomycin 30 mg/kg dose |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Yuen, BSc. Pharm | Fraser Health Authority | 604-520-4005 | anna.yuen@fraserhealth.ca |
Not provided
| ID | Term |
|---|---|
| D018461 | Soft Tissue Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| vancomycin |
| Drug |
vancomycin 15 mg/kg intravenous administered twice daily (standard dosing) |
|
| 5 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| subjects |
|
|
| Secondary | 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. | Posted | Number | participants | 5 days |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Vancomycin Twice Daily | Subject receives vancomycin 15 mg/kg twice daily | 0 | 4 | 0 | 4 |
Not provided
Not provided
| D000602 |
| Amino Acids, Peptides, and Proteins |
| Indeterminate |
|