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OpenTrials
Completed

NCT Number: NCT01037192

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

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.

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Key information

Conditions

Skin and Soft Tissue Infections Infections Soft Tissue Infections

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vancomycin

Drug

vancomycin 30 mg/kg intravenous administered once daily

Primary outcomes

  1. Clinical Efficacy

    Time frame: 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 outcomes

  1. Microbiological Efficacy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fraser Health

Other

Registry information

Acronym: VOD

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 22, 2009
Registry last updated
Aug 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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