Infectious Disease
Conditions
Keywords
Vancomycin, Therapeutic Levels, Infectious Disease, Recommendations
Brief summary
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.
Detailed description
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.
Interventions
DRUGVancomycin
15mg/kg
Sponsors
Christiana Care Health Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Treated in Christiana Emergency Department * Receiving Vancomycin for an infection or presumed infection * Being admitted to Christiana Hospital * Planned continued use of Vancomycin after admission.
Exclusion criteria
* Less than 18 years of age * Weight greater than 120 kg. * Concurrent use of aminoglycosides or acyclovir * Sepsis patients being admitted to ICU with presumed diagnosis of pneumonia * Patients currently undergoing dialysis * Pregnant or breast feeding * No plan to continue Vancomycin after admission. * Creatinine clearance less than 50ml/min.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants First Achieving Therapeutic Levels at 36 Hours | 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. |
| Percentage of Participants First Achieving Therapeutic Levels at 12 Hours | 12 hours | Percentage of patients reaching a therapeutic level defined as greater than 15 mcg/mL |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Drug 1 Vancomycin 15mg/kg
Vancomycin : 15mg/kg | 49 |
| Study Drug 2 Vancomycin 30mg/kg
Vancomycin : 30mg/kg | 50 |
| Total | 99 |
Baseline characteristics
| Characteristic | Study Drug 1 | Study Drug 2 | Total |
|---|---|---|---|
| Age, Customized Greater than 18 years of age | 49 participants | 50 participants | 99 participants |
| Region of Enrollment United States | 49 participants | 50 participants | 99 participants |
| Sex: Female, Male Female | 24 Participants | 22 Participants | 46 Participants |
| Sex: Female, Male Male | 25 Participants | 28 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 49 | 3 / 50 |
| serious Total, serious adverse events | 0 / 49 | 2 / 50 |
Outcome results
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
Time frame: 12 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Drug 1 | Percentage of Participants First Achieving Therapeutic Levels at 12 Hours | 3 percentage of participants |
| Study Drug 2 | Percentage of Participants First Achieving Therapeutic Levels at 12 Hours | 34 percentage of participants |
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.
Time frame: 36 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Drug 1 | Percentage of Participants First Achieving Therapeutic Levels at 36 Hours | 20 percentage of participants |
| Study Drug 2 | Percentage of Participants First Achieving Therapeutic Levels at 36 Hours | 18 percentage of participants |