Vancomycin Dosage Strategy Based on a Trough Concentration Model

Study Overview
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Brief Summary
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Study design: Allocation: Randomized Endpoint classification: Efficacy study Masking: Open label Primary purpose: Treatment Primary endpoint: Incidence of reaching the target serum trough concentration Secondary endpoint: Clinical efficiency, Antibiotic use, acute kidney injury.

Detailed Description
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This is a prospective randomized control trial. There are two groups, study group and control group. Patients of study group accepted vancomycin strategies decided by a serum trough concentration model, and patients of control group accepted vancomycin dosage decided by attending physician. The primary endpoint is the incidence of reaching the target serum trough concentration, the secondary endpoint are clinical efficiency, antibiotic use and side effects such as acute kidney injury, etc.

Official Title
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Clinical Evaluation of a Vancomycin Dosage Strategy Based on a Serum Trough Concentration Model in Elderly Patients With Severe Pneumonia

Conditions
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Pneumonia, Staphylococcal

Intervention / Treatment
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* Drug: Individualized therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with doubted or diagnosed Methicillin-resistant Staphylococcus aureus severe pneumonia, and need vancomycin treatment. Sixty years and older. Exclusion Criteria: younger than 60 years old Accepted blood purification therapy Pregnancy Positive HIV antibody titre Had known or suspected tuberculosis or other infections caused by fungi at baseline.

Ages Eligible for Study
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Minimum Age: 60 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 |
| --- | --- |
| Experimental: Study group<br>Patients of study group will accept vancomycin strategies decided by a serum trough concentration model. | Drug: Individualized therapy<br>* Dosage of Vancomycin decided by a serum trough concentration model, instead of decided by attending physician<br>* Other names: Vancomycin;|
| No Intervention: Control group<br>Patients of control group will accept vancomycin dosages decided by attending physician. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of vancomycin therapeutic serum trough concentrations | The proportion of patients with vancomycin serum trough concentrations reaching target concentrations (≥15mg/L)will be compared between study group and control group | before the fifth vancomycin dosage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success rate | the proportion of patients with clinical success | Seven days after vancomycin withdrawal. | 
| Vancomycin doses | Vancomycin daily doses and totally doses | At the end of vancomycin therapy, an average of 10 days. | 
| Incidence of acute kidney injury | The incidence of vancomycin-associated acute kidney injury | At the end of vancomycin treatment, an average of 10 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pneumonia, vancomycin, trough concentration, elderly patients