More than 40% of patients presenting with acute bacterial skin and skin structure infection (ABSSSI) to the Barnes-Jewish Hospital (BJH) emergency department (ED) are admitted for intravenous antibiotics. There is growing evidence to suggest that many hospital admissions for uncomplicated ABSSSI due to Gram-positive bacteria could be avoided with an alternative treatment strategy employing newer long-acting antibiotics. Coupled with close outpatient follow-up, such an alternative hospital avoidance strategy has the potential to improve quality and value of care for patients with uncomplicated ABSSSI and optimize use of limited inpatient healthcare resources.
This study seeks to establish the feasibility and acceptability of an alternative treatment strategy for uncomplicated acute bacterial skin and skin structure infection (ABSSSI) in the Barnes Jewish Hospital (BJH) Emergency Department (ED) focusing on hospital admission avoidance using single-dose, long-acting antimicrobial therapy complemented by close follow-up in the ambulatory setting. The extended half-life of these new antimicrobials (dalbavancin, oritavancin) allows for an effective treatment course of \>7 days with a single dose, which is the accepted duration for which ABSSSI is usually treated with daily doses of other intravenous or oral antimicrobials. The investigators believe that such an approach will conserve hospital resources by reducing admissions for uncomplicated ABSSSI while delivering comparable if not superior care for this disease, allowing optimal utilization of BJH inpatient beds for other serious medical conditions requiring inpatient care. The investigators believe this novel alternative approach will allow hospitals such as BJH to more cost-effectively and efficiently manage ABSSSI patients. This study will reduce the number of \>2 midnight observation admissions to BJH for ABSSSI, thereby improving inpatient capacity to care for patients requiring \>2 midnight hospital inpatient admission. The investigators will conduct a randomized controlled trial comparing patients treated with a single-dose of intravenous dalbavancin (an antibiotic that has been FDA-approved for the treatment of ABSSSI and is currently being used in clinical practice in the U.S.) and discharged home from the ED with close ambulatory care follow-up in clinic vs. patients treated with "usual care" (hospital admission for multiple doses of intravenous vancomycin or other antibiotic directed towards Gram-positive bacteria). Clinical outcomes, healthcare utilization, hospital costs, and patient satisfaction will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Dalbavancin, a lipoglycopeptide antibiotic, has been approved by the FDA for the treatment of ABSSSI caused by Gram-positive bacteria. A single dose of dalbavancin will be administered in the Emergency Department followed by discharge with close outpatient infectious disease clinic follow-up.
Barnes-Jewish Hospital
St Louis, Missouri, United States
Healthcare Utilization Related to ABSSSI
Repeat ED visit(s) within 28 days, need for hospital admission(s) to receive intravenous antibiotics ("alternative treatment strategy" arm), or need for switch to different oral or intravenous antibiotic to treat ABSSSI ("usual care" arm)
Time frame: 28 days
Healthcare Cost Related to ABSSSI Management
Indirect/direct costs associated with ED visit(s), indirect/direct costs associated with hospital admission(s)
Time frame: 28 days
Clinical Response
Change in ABSSSI lesion area (cm2)
Time frame: 28 days
Clinical Success
Clinical resolution of symptoms, need for additional intravenous/oral antibiotic therapy
Time frame: 28 days
Overall Patient Satisfaction Based on Standardized Measures
Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey items
Time frame: 28 days
Patient Satisfaction Specific to ABSSSI Care
Targeted survey questions specific to ABSSSI and patient-centered outcomes with relation to alternative treatment strategy vs. usual care
Time frame: 28 days
Patient Safety
Adverse drug events
Time frame: 28 days
Quality of Life Measured Using RAND SF-36 Survey
RAND SF-36
Time frame: 28 days
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