Vancomycin Dosage Adjustment for MRSA Infections

January 20, 2018 updated by: Pinyo Rattanaumpawan

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

An open-label randomized controlled trial to compare two vancomycin dosage adjustment methods

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

An open-label randomized controlled trial to compare two vancomycin dosage adjustment methods; a vancomycin trough concentration method and a equation-based method.

Study Type

Interventional

Enrollment (Anticipated)

114

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Siriraj Hospital
        • Contact:
        • Principal Investigator:
          • Pinyo Rattanaumpawan, MD, MSCE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Thai hospitalized patients, age>18 years
  2. Require vancomycin therapy ≥ 3 days
  3. Documented MRSA infection including pneumonia, bacteremia, intra-abdominal infection or skin and soft tissue infection
  4. Have been checked for serum creatinine within 48 hours and serum albumin within 7 days prior to enrollment
  5. Received an appropriate loading dose of vancomycin
  6. Have been treated with an appropriate maintenance dose of vancomycin
  7. Willing to sign an informed consent

Exclusion Criteria:

  1. CrCl< 10 ml/min or receiving renal replacement therapy
  2. Pregnancy or lactation
  3. Actual BW> 90 kg
  4. Serum albumin <2 g/dl
  5. Having an active cancer or receiving chemotherapy
  6. Hx of vancomycin allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vancomycin trough concentration method
vancomycin dosage will be adjusted by the trough concentration method
Drug: Vancomycin trough concentration method
Vancomycin dosage will be adjusted according to the trough concentration method
Other Names:
  • control arm
Experimental: Vancomycin equation-based method
vancomycin dosage will be adjusted by the equation-based method
Drug: Vancomycin equation-based method
Vancomycin dosage will be adjusted according to the equation-based method
Other Names:
  • intervention arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response
Time Frame: End of therapy (an average of 2 weeks)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal adverse event
Time Frame: Day 5 after vancomycin therapy
Double serum creatinine
Day 5 after vancomycin therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pinyo Rattanaumpawan

Investigators

  • Principal Investigator: pinyo rattanaumpawan, md, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

January 20, 2018

First Posted (Actual)

January 26, 2018

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 20, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101/2559(EC1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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