Skin and Soft Tissue Infections
Conditions
Keywords
outpatient, skin and soft tissue infections, vancomycin intravenous
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.
Interventions
DRUGvancomycin
vancomycin 30 mg/kg intravenous administered once daily
Sponsors
Fraser Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Efficacy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological Efficacy | 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. |
Countries
Canada
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Vancomycin Once Daily Subject receives vancomycin 30 mg/kg dose | 3 |
| Vancomycin Twice Daily Subject receives vancomycin 15 mg/kg twice daily | 1 |
| Total | 4 |
Baseline characteristics
| Characteristic | Vancomycin Twice Daily | Vancomycin Once Daily | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Continuous | 49 years | 48 years STANDARD_DEVIATION 12 | 48 years STANDARD_DEVIATION 10 |
| Region of Enrollment Canada | 1 participants | 3 participants | 4 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
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.
Time frame: 5 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vancomycin Once Daily | Clinical Efficacy | 2 participants |
| Vancomycin Twice Daily | Clinical Efficacy | 0 participants |
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.
Time frame: 5 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vancomycin Once Daily | Microbiological Efficacy | Favourable | 0 participants |
| Vancomycin Once Daily | Microbiological Efficacy | Unfavourable | 1 participants |
| Vancomycin Once Daily | Microbiological Efficacy | Indeterminate | 2 participants |
| Vancomycin Twice Daily | Microbiological Efficacy | Favourable | 0 participants |
| Vancomycin Twice Daily | Microbiological Efficacy | Unfavourable | 0 participants |
| Vancomycin Twice Daily | Microbiological Efficacy | Indeterminate | 1 participants |