Vancomycin Dosage Adjustment for MRSA Infections
A Comparative Efficacy Study of Vancomycin Dosage Adjustment by Equation-based Method and Vancomycin Trough Concentration Method for Treatment of Infections Caused by Methicillin Resistant Staphylococcus Aureus
1 other identifier
interventional
114
1 country
1
Brief Summary
An open-label randomized controlled trial to compare two vancomycin dosage adjustment methods
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedFirst Posted
Study publicly available on registry
January 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedJanuary 26, 2018
January 1, 2018
1.9 years
June 3, 2016
January 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical response
Clinical response will be evaluated at the end of therapy (EOT) by a clinician investigator. Clinical response will be classified as good clinical response, partial clinical response, poor clinical response and undetermined.
End of therapy (an average of 2 weeks)
Secondary Outcomes (1)
Renal adverse event
Day 5 after vancomycin therapy
Study Arms (2)
Vancomycin trough concentration method
ACTIVE COMPARATORvancomycin dosage will be adjusted by the trough concentration method
Vancomycin equation-based method
EXPERIMENTALvancomycin dosage will be adjusted by the equation-based method
Interventions
Vancomycin dosage will be adjusted according to the equation-based method
Vancomycin dosage will be adjusted according to the trough concentration method
Eligibility Criteria
You may qualify if:
- Thai hospitalized patients, age\>18 years
- Require vancomycin therapy ≥ 3 days
- Documented MRSA infection including pneumonia, bacteremia, intra-abdominal infection or skin and soft tissue infection
- Have been checked for serum creatinine within 48 hours and serum albumin within 7 days prior to enrollment
- Received an appropriate loading dose of vancomycin
- Have been treated with an appropriate maintenance dose of vancomycin
- Willing to sign an informed consent
You may not qualify if:
- CrCl\< 10 ml/min or receiving renal replacement therapy
- Pregnancy or lactation
- Actual BW\> 90 kg
- Serum albumin \<2 g/dl
- Having an active cancer or receiving chemotherapy
- Hx of vancomycin allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Siriraj Hospital
Bangkok, 10700, Thailand
Study Officials
- PRINCIPAL INVESTIGATOR
pinyo rattanaumpawan, md
Mahidol University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 3, 2016
First Posted
January 26, 2018
Study Start
October 1, 2016
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
January 26, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share