Vancomycin Dosage Adjustment for MRSA Infections

Study Overview
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Brief Summary
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An open-label randomized controlled trial to compare two vancomycin dosage adjustment methods

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

Official Title
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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

Conditions
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Methicillin-Resistant Staphylococcus Aureus

Intervention / Treatment
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* Drug: Vancomycin equation-based method
* Drug: Vancomycin trough concentration method


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vancomycin trough concentration method<br>vancomycin dosage will be adjusted by the trough concentration method | Drug: Vancomycin trough concentration method<br>* Vancomycin dosage will be adjusted according to the trough concentration method<br>* Other names: control arm;|
| Experimental: Vancomycin equation-based method<br>vancomycin dosage will be adjusted by the equation-based method | Drug: Vancomycin equation-based method<br>* Vancomycin dosage will be adjusted according to the equation-based method<br>* Other names: intervention arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methicillin-Resistant Staphylococcus aureus, Vancomycin