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

Fraser Health

Status: Completed

Conditions: Skin and Soft Tissue Infections

Treatments: Drug: vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01037192

VOD

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Vanco once daily

Experimental group

Description:

Subject receives vancomycin 30 mg/kg dose

Treatment:

Drug: vancomycin

Vanco twice daily

Active Comparator group

Description:

Subject receives vancomycin 15 mg/kg twice daily

Treatment:

Drug: vancomycin