Skin Infection
Conditions
Keywords
Acute bacterial skin and skin structure infections, Hospital avoidance, Antibiotic therapy, Dalbavancin, Emergency department
Brief summary
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.
Detailed description
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.
Interventions
DRUGDalbavancin
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.
Sponsors
The Foundation for Barnes-Jewish Hospital
Allergan
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study will be single center, randomized, non-blinded study comparing two active treatment arms to treat uncomplicated ABSSSI suspected to be due to Gram-positive bacteria: * Alternative treatment strategy comprised of a single dose of dalbavancin administered in the BJH ED or ED observation unit followed by discharge w/ close Infectious Disease outpatient clinic follow-up vs. * Usual care (i.e., hospital admission for intravenous antibiotics - typically, vancomycin) - antibiotic and doses to be determined at the discretion of the treating clinician (both in the BJH ED and on the BJH inpatient ward)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (age ≥18 years) * Diagnosis of uncomplicated ABSSSI suspected to be due to Gram-positive bacteria by treating ED clinician, with presence of the following: 1. Skin lesion size ≥75 cm2 (measured by area of erythema, edema, and/or induration) AND 2. Signs of systemic inflammation (at least 1 of the following: WBC \>12,000 or \<4,000 cells/mm3; ≥10% immature neutrophils on peripheral smear; temperature \>38.3˚C or \<36˚C; heart rate \>90 bpm, respiratory rate \>20 bpm). Signs of systemic inflammation not required if the patient is age \>70 years, has diabetes mellitus, or has been treated with immunosuppressive or chemotherapy in the past 90 days. * Clinical determination by treating ED clinician that patient will need hospital admission for the sole purpose of receiving intravenous antibiotics directed only towards Gram-positive bacteria (e.g., vancomycin, cefazolin) to treat uncomplicated ABSSSI
Exclusion criteria
* Risk for ABSSSI due to Gram-negative bacteria (neutropenia with absolute neutrophil count \<500 cells/µL, HIV or severely immunocompromised, burns, infection after trauma or as a result of an aquatic environment, infection after skin graft) * Any abscess requiring bedside or operative drainage * Infection due to a vascular catheter or prosthetic device * Infection of a diabetic foot ulcer or decubitus ulcer * Necrotizing soft tissue infection * Sepsis (quick SOFA score ≥2) or septic shock (requiring vasopressors to maintain mean arterial pressure ≥65 mmHg despite resuscitation with at least 30mL/kg of IV crystalloid within first 3 hours) * Recent antibiotics in prior 14 days * Hypersensitivity to glycopeptides (vancomycin, televancin, dalbavancin, oritavancin) * Severe renal insufficiency (CrCl \<30 mL/min) * Severe hepatic insufficiency (Child-Pugh Class C) * Pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Utilization Related to ABSSSI | 28 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response | 28 days | Change in ABSSSI lesion area (cm2) |
| Clinical Success | 28 days | Clinical resolution of symptoms, need for additional intravenous/oral antibiotic therapy |
| Overall Patient Satisfaction Based on Standardized Measures | 28 days | Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey items |
| Healthcare Cost Related to ABSSSI Management | 28 days | Indirect/direct costs associated with ED visit(s), indirect/direct costs associated with hospital admission(s) |
| Patient Safety | 28 days | Adverse drug events |
| Quality of Life Measured Using RAND SF-36 Survey | 28 days | RAND SF-36 |
| Patient Satisfaction Specific to ABSSSI Care | 28 days | Targeted survey questions specific to ABSSSI and patient-centered outcomes with relation to alternative treatment strategy vs. usual care |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alternative Treatment Strategy Patient will receive a single dose of dalbavancin administered in the BJH ED or ED observation unit for ABSSSI followed by discharge w/ close Infectious Disease outpatient clinic follow-up.
Dalbavancin: 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. | 6 |
| Usual Care Patients will receive usual care (i.e., hospital admission for intravenous antibiotics - typically, vancomycin) - antibiotic and doses to be determined at the discretion of the treating clinician (both in the BJH ED and on the BJH inpatient ward). | 5 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 |
Baseline characteristics
| Characteristic | Usual Care | Total | Alternative Treatment Strategy |
|---|---|---|---|
| Age, Continuous | 42.4 years | 42.9 years | 43.3 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 0 / 6 | 0 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 |
Outcome results
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alternative Treatment Strategy | Healthcare Utilization Related to ABSSSI | Number of participants with repeat ED visit | 0 Participants |
| Alternative Treatment Strategy | Healthcare Utilization Related to ABSSSI | Number of participants with need for hospital admission(s) to receive IV antibiotics | 1 Participants |
| Alternative Treatment Strategy | Healthcare Utilization Related to ABSSSI | Number of patients without additional healthcare utilization to treat ABSSSI | 5 Participants |
| Alternative Treatment Strategy | Healthcare Utilization Related to ABSSSI | Number of participants with need for switch to different oral antibiotic | 0 Participants |
| Usual Care | Healthcare Utilization Related to ABSSSI | Number of participants with need for switch to different oral antibiotic | 0 Participants |
| Usual Care | Healthcare Utilization Related to ABSSSI | Number of participants with repeat ED visit | 1 Participants |
| Usual Care | Healthcare Utilization Related to ABSSSI | Number of patients without additional healthcare utilization to treat ABSSSI | 4 Participants |
| Usual Care | Healthcare Utilization Related to ABSSSI | Number of participants with need for hospital admission(s) to receive IV antibiotics | 0 Participants |
Secondary
Clinical Response
Change in ABSSSI lesion area (cm2)
Time frame: 28 days
Population: Data were not collected
Secondary
Clinical Success
Clinical resolution of symptoms, need for additional intravenous/oral antibiotic therapy
Time frame: 28 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alternative Treatment Strategy | Clinical Success | Number of participants with clinical resolution of symptoms | 4 Participants |
| Alternative Treatment Strategy | Clinical Success | Number of participants with need for additional intravenous/oral antibiotic therapy | 0 Participants |
| Usual Care | Clinical Success | Number of participants with clinical resolution of symptoms | 1 Participants |
| Usual Care | Clinical Success | Number of participants with need for additional intravenous/oral antibiotic therapy | 0 Participants |
Secondary
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
Population: Data were not collected
Secondary
Overall Patient Satisfaction Based on Standardized Measures
Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey items
Time frame: 28 days
Population: Data were not collected
Secondary
Patient Safety
Adverse drug events
Time frame: 28 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alternative Treatment Strategy | Patient Safety | Number of participants with an adverse drug event | 0 Participants |
| Alternative Treatment Strategy | Patient Safety | Number of participants without an adverse drug event | 4 Participants |
| Usual Care | Patient Safety | Number of participants with an adverse drug event | 0 Participants |
| Usual Care | Patient Safety | Number of participants without an adverse drug event | 1 Participants |
Secondary
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
Population: Data were not collected
Secondary
Quality of Life Measured Using RAND SF-36 Survey
RAND SF-36
Time frame: 28 days
Population: Data were not collected