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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03412500

Enrollment

114

Registered

2018-01-26

Start date

2016-10-31

Completion date

2018-09-30

Last updated

2018-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methicillin-Resistant Staphylococcus Aureus

Keywords

Methicillin-Resistant Staphylococcus aureus, Vancomycin

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.

Interventions

DRUGVancomycin equation-based method

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

DRUGVancomycin trough concentration method

Vancomycin dosage will be adjusted according to the trough concentration method

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical response	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.

Secondary

Measure	Time frame	Description
Renal adverse event	Day 5 after vancomycin therapy	Double serum creatinine

Countries

Thailand

Contacts

Primary Contactpinyo rattanaumpawan, md

pinyo.rat@mahidol.ac.th897778176

Backup Contactdawis jiravijitkul, md

els1008@hotmail.com6624197783

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026