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

Information source: Fraser Health
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Skin and Soft Tissue Infections

Intervention: vancomycin (Drug); vancomycin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Fraser Health

Official(s) and/or principal investigator(s):
Anna Yuen, BSc. Pharm, Principal Investigator, Affiliation: Fraser Health

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Clinical Efficacy

Secondary outcome: Microbiological Efficacy

Eligibility

Minimum age: 19 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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 ┬Ámol/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)

Locations and Contacts

Royal Columbian Hospital, New Westminster, British Columbia V3L 3W7, Canada
Additional Information

Starting date: March 2010
Last updated: June 11, 2011

Page last updated: August 23, 2015

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