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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections

Conditions
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Skin and Soft Tissue Infections

Intervention / Treatment
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* Drug: vancomycin
* Drug: vancomycin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vanco once daily<br>Subject receives vancomycin 30 mg/kg dose | Drug: vancomycin<br>* vancomycin 30 mg/kg intravenous administered once daily<br>|
| Active Comparator: Vanco twice daily<br>Subject receives vancomycin 15 mg/kg twice daily | Drug: vancomycin<br>* vancomycin 15 mg/kg intravenous administered twice daily (standard dosing)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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outpatient, skin and soft tissue infections, vancomycin intravenous