NCT01037192

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 22, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
10 months until next milestone

Results Posted

Study results publicly available

July 8, 2011

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

6 months

First QC Date

December 18, 2009

Results QC Date

May 10, 2011

Last Update Submit

August 18, 2015

Conditions

Skin and Soft Tissue Infections

Keywords

outpatientskin and soft tissue infectionsvancomycin intravenous

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Microbiological Efficacy

    5 days

Study Arms (2)

Vanco once daily

EXPERIMENTAL

Subject receives vancomycin 30 mg/kg dose

Drug: vancomycin

Vanco twice daily

ACTIVE COMPARATOR

Subject receives vancomycin 15 mg/kg twice daily

Drug: vancomycin

Interventions

vancomycinDRUG

vancomycin 30 mg/kg intravenous administered once daily

Vanco once daily

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Related Publications (1)

  • Cohen E, Dadashev A, Drucker M, Samra Z, Rubinstein E, Garty M. Once-daily versus twice-daily intravenous administration of vancomycin for infections in hospitalized patients. J Antimicrob Chemother. 2002 Jan;49(1):155-60. doi: 10.1093/jac/49.1.155.

    PMID: 11751780RESULT

MeSH Terms

Conditions

Soft Tissue Infections

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Limitations and Caveats

The main limitation was low enrollment, primarily caused by stringent inclusion criteria. The age limitation was required to ensure safe vancomycin administration. The weight limitation was required for medication preparation.

Results Point of Contact

Title
Anna Yuen, BSc. Pharm
Organization
Fraser Health Authority
anna.yuen@fraserhealth.ca
604-520-4005

Study Officials

  • Anna Yuen, BSc. Pharm

    Fraser Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharmacist

Study Record Dates

First Submitted

December 18, 2009

First Posted

December 22, 2009

Study Start

March 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

August 27, 2015

Results First Posted

July 8, 2011

Record last verified: 2015-08

Locations

CA(1)