Back to results

Vancomycin Dosage Adjustment for MRSA Infections

Primary Purpose

Methicillin-Resistant Staphylococcus Aureus

Status

Unknown status

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Vancomycin equation-based method

Vancomycin trough concentration method

About this trial

This is an interventional treatment trial for Methicillin-Resistant Staphylococcus Aureus focused on measuring Methicillin-Resistant Staphylococcus aureus, Vancomycin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Vancomycin trough concentration method

Vancomycin equation-based method

Arm Description

vancomycin dosage will be adjusted by the trough concentration method

vancomycin dosage will be adjusted by the equation-based method

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Renal adverse event

Double serum creatinine

Full Information

NCT ID

NCT03412500

First Posted

June 3, 2016

Last Updated

January 20, 2018

Sponsor

Pinyo Rattanaumpawan

1. Study Identification

Unique Protocol Identification Number

NCT03412500

Brief Title

Vancomycin Dosage Adjustment for MRSA Infections

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 2016 (undefined)

Primary Completion Date

September 2018 (Anticipated)

Study Completion Date

September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Pinyo Rattanaumpawan

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Methicillin-Resistant Staphylococcus Aureus

Keywords

Methicillin-Resistant Staphylococcus aureus, Vancomycin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vancomycin trough concentration method

Arm Type

Active Comparator

Arm Description

vancomycin dosage will be adjusted by the trough concentration method

Arm Title

Vancomycin equation-based method

Arm Type

Experimental

Arm Description

vancomycin dosage will be adjusted by the equation-based method

Intervention Type

Drug

Intervention Name(s)

Vancomycin equation-based method

Other Intervention Name(s)

intervention arm

Intervention Description

Vancomycin dosage will be adjusted according to the equation-based method

Intervention Type

Drug

Intervention Name(s)

Vancomycin trough concentration method

Other Intervention Name(s)

control arm

Intervention Description

Vancomycin dosage will be adjusted according to the trough concentration method

Primary Outcome Measure Information:

Title

Clinical response

Description

Time Frame

End of therapy (an average of 2 weeks)

Secondary Outcome Measure Information:

Title

Renal adverse event

Description

Double serum creatinine

Time Frame

Day 5 after vancomycin therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

pinyo rattanaumpawan, md

Phone

897778176

pinyo.rat@mahidol.ac.th

First Name & Middle Initial & Last Name or Official Title & Degree

dawis jiravijitkul, md

Phone

6624197783

els1008@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

pinyo rattanaumpawan, md

Organizational Affiliation

Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Siriraj Hospital

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pinyo Rattanaumpawan, MD, MSCE

Phone

6624197783

pinyo.rat@mahidol.ac.th

First Name & Middle Initial & Last Name & Degree

Pinyo Rattanaumpawan, MD, MSCE

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Vancomycin Dosage Adjustment for MRSA Infections

We'll reach out to this number within 24 hrs