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Funding and recruitment limited by pandemic
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| Name | Class |
|---|---|
| The Foundation for Barnes-Jewish Hospital | OTHER |
| Allergan | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alternative treatment strategy | Active Comparator | 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. |
|
| Usual care | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalbavancin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Cost Related to ABSSSI Management | Indirect/direct costs associated with ED visit(s), indirect/direct costs associated with hospital admission(s) | 28 days |
| Clinical Response | Change in ABSSSI lesion area (cm2) |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Y Liang, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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) | Posted | Count of Participants | Participants | 28 days |
|
28 days
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Liang | Washington University School of Medicine | 3017470750 | syliang@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2019 | Sep 23, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002481 | Cellulitis |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D012874 | Skin Diseases, Infectious |
| D007239 | Infections |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C469289 | dalbavancin |
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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:
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|
|
| 28 days |
| Clinical Success | Clinical resolution of symptoms, need for additional intravenous/oral antibiotic therapy | 28 days |
| Overall Patient Satisfaction Based on Standardized Measures | Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey items | 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 | 28 days |
| Patient Safety | Adverse drug events | 28 days |
| Quality of Life Measured Using RAND SF-36 Survey | RAND SF-36 | 28 days |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| 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). |
|
|
| Secondary | Healthcare Cost Related to ABSSSI Management | Indirect/direct costs associated with ED visit(s), indirect/direct costs associated with hospital admission(s) | Data were not collected | Posted | 28 days |
|
|
| Secondary | Clinical Response | Change in ABSSSI lesion area (cm2) | Data were not collected | Posted | 28 days |
|
|
| Secondary | Clinical Success | Clinical resolution of symptoms, need for additional intravenous/oral antibiotic therapy | Posted | Count of Participants | Participants | 28 days |
|
|
|
| Secondary | Overall Patient Satisfaction Based on Standardized Measures | Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey items | Data were not collected | Posted | 28 days |
|
|
| 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 | Data were not collected | Posted | 28 days |
|
|
| Secondary | Patient Safety | Adverse drug events | Posted | Count of Participants | Participants | 28 days |
|
|
|
| Secondary | Quality of Life Measured Using RAND SF-36 Survey | RAND SF-36 | Data were not collected | Posted | 28 days |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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). | 0 | 5 | 0 | 5 | 0 | 5 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |