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In 2008, our ED administered an average of 245 doses of vancomycin per month. Currently there is no consistency in the ED practice in regards to vancomycin dosing. In 2009, the IDSA put forth new recommendations for vancomycin dosing in order to achieve therapeutic levels more rapidly. It has been hypothesized that if therapeutic levels are reached more rapidly then patients will in turn have better clinical outcomes and that the development of resistant organisms will be decreased. Methicillin resistant Staphylococcus aureus (MRSA) has emerged as one of the most deadly pathogens that are currently plaguing our patient population. Vancomycin is one of only a few antibiotics that are effective for treating MRSA. It is imperative that the ED physicians consistently and correctly dose vancomycin in order to give the patients the best chance to fight infection while helping to prevent further resistance in this already highly resistant organism. It is believed this study will reveal that the new dosing recommendations by the IDSA will lead to the achievement of therapeutic levels more rapidly. This information will in turn help to convince ED physicians that a change in current clinical practice is warranted and ultimately lead to better clinically outcomes for the patients.
Recently, the Infectious Disease Society of America (IDSA) has released new dosing recommendations for intravenous (IV) vancomycin. These new recommendations suggest administering an initial dose of 25-30 mg/kg of vancomycin as opposed to 10-15 mg/kg which is more traditionally done. Currently in the Emergency Department (ED) some practitioners are using the new IDSA dosing recommendations for vancomycin, while other practitioners have not changed their clinical practice. There is currently little data available to suggest that implementing these new vancomycin dosing regimens in the ED will achieve therapeutic vancomycin levels more rapidly than our traditional dosing practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Drug 1 | Active Comparator | Vancomycin 15mg/kg |
|
| Study Drug 2 | Active Comparator | Vancomycin 30mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug | 15mg/kg |
| |
| Vancomycin |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants First Achieving Therapeutic Levels at 36 Hours | The objective is to determine if therapeutic levels were reached more rapidly with the implementation of an initial vancomycin loading dose of 30 mg/kg as compared to 15mg/kg. | 36 hours |
| Percentage of Participants First Achieving Therapeutic Levels at 12 Hours | Percentage of patients reaching a therapeutic level defined as greater than 15 mcg/mL | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Levine, MD | Christiana Care Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chrisitana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Drug 1 | Vancomycin 15mg/kg Vancomycin : 15mg/kg |
| FG001 | Study Drug 2 | Vancomycin 30mg/kg Vancomycin : 30mg/kg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Drug 1 | Vancomycin 15mg/kg Vancomycin : 15mg/kg |
| BG001 | Study Drug 2 | Vancomycin 30mg/kg Vancomycin : 30mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants First Achieving Therapeutic Levels at 36 Hours | The objective is to determine if therapeutic levels were reached more rapidly with the implementation of an initial vancomycin loading dose of 30 mg/kg as compared to 15mg/kg. | Posted | Number | percentage of participants | 36 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Drug 1 | Vancomycin 15mg/kg Vancomycin : 15mg/kg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New onset Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction | Immune system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deb Marco | Christiana Care Health System | 302 733-4130 | dmarco@christianacare.org |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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| Drug |
30mg/kg |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Percentage of Participants First Achieving Therapeutic Levels at 12 Hours | Percentage of patients reaching a therapeutic level defined as greater than 15 mcg/mL | Posted | Number | percentage of participants | 12 hours |
|
|
|
| 0 |
| 49 |
| 3 |
| 49 |
| EG001 | Study Drug 2 | Vancomycin 30mg/kg Vancomycin : 30mg/kg | 2 | 50 | 3 | 50 |
| Renal failure | Renal and urinary disorders | Systematic Assessment |
|
| Flushing | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D000602 |
| Amino Acids, Peptides, and Proteins |