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

F

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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