Pneumonia, Staphylococcal
Conditions
Keywords
pneumonia, vancomycin, trough concentration, elderly patients
Brief summary
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
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.
Interventions
Dosage of Vancomycin decided by a serum trough concentration model, instead of decided by attending physician
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of vancomycin therapeutic serum trough concentrations | before the fifth vancomycin dosage | The proportion of patients with vancomycin serum trough concentrations reaching target concentrations (≥15mg/L)will be compared between study group and control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vancomycin doses | At the end of vancomycin therapy, an average of 10 days. | Vancomycin daily doses and totally doses |
| Clinical success rate | Seven days after vancomycin withdrawal. | the proportion of patients with clinical success |
| Incidence of acute kidney injury | At the end of vancomycin treatment, an average of 10 days. | The incidence of vancomycin-associated acute kidney injury |
Countries
China
Outcome results
None listed