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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Patients of study group will accept vancomycin strategies decided by a serum trough concentration model. |
|
| Control group | No Intervention | Patients of control group will accept vancomycin dosages decided by attending physician. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized therapy | Drug | Dosage of Vancomycin decided by a serum trough concentration model, instead of decided by attending physician |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qingtao Zhou, Dr. | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospita | Beijing | Beijing Municipality | 100191 | China |
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| ID | Term |
|---|---|
| D011023 | Pneumonia, Staphylococcal |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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| 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. |
| D007239 | Infections |
| D018410 | Pneumonia, Bacterial |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |