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Hospital Avoidance Strategies for ABSSSI

Primary Purpose

Skin Infection

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dalbavancin
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Infection focused on measuring Acute bacterial skin and skin structure infections, Hospital avoidance, Antibiotic therapy, Dalbavancin, Emergency department

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barnes-Jewish Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Alternative treatment strategy

Usual care

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Healthcare Cost Related to ABSSSI Management
Indirect/direct costs associated with ED visit(s), indirect/direct costs associated with hospital admission(s)
Clinical Response
Change in ABSSSI lesion area (cm2)
Clinical Success
Clinical resolution of symptoms, need for additional intravenous/oral antibiotic therapy
Overall Patient Satisfaction Based on Standardized Measures
Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey items
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
Patient Safety
Adverse drug events
Quality of Life Measured Using RAND SF-36 Survey
RAND SF-36

Full Information

First Posted
December 4, 2017
Last Updated
November 11, 2022
Sponsor
Washington University School of Medicine
Collaborators
The Foundation for Barnes-Jewish Hospital, Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT03372941
Brief Title
Hospital Avoidance Strategies for ABSSSI
Official Title
Hospital Avoidance Strategies for Treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Funding and recruitment limited by pandemic
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
October 14, 2021 (Actual)
Study Completion Date
October 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
The Foundation for Barnes-Jewish Hospital, Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Infection
Keywords
Acute bacterial skin and skin structure infections, Hospital avoidance, Antibiotic therapy, Dalbavancin, Emergency department

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alternative treatment strategy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Dalbavancin
Other Intervention Name(s)
Dalvance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Healthcare Utilization Related to ABSSSI
Description
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
Secondary Outcome Measure Information:
Title
Healthcare Cost Related to ABSSSI Management
Description
Indirect/direct costs associated with ED visit(s), indirect/direct costs associated with hospital admission(s)
Time Frame
28 days
Title
Clinical Response
Description
Change in ABSSSI lesion area (cm2)
Time Frame
28 days
Title
Clinical Success
Description
Clinical resolution of symptoms, need for additional intravenous/oral antibiotic therapy
Time Frame
28 days
Title
Overall Patient Satisfaction Based on Standardized Measures
Description
Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey items
Time Frame
28 days
Title
Patient Satisfaction Specific to ABSSSI Care
Description
Targeted survey questions specific to ABSSSI and patient-centered outcomes with relation to alternative treatment strategy vs. usual care
Time Frame
28 days
Title
Patient Safety
Description
Adverse drug events
Time Frame
28 days
Title
Quality of Life Measured Using RAND SF-36 Survey
Description
RAND SF-36
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Skin lesion size ≥75 cm2 (measured by area of erythema, edema, and/or induration) AND 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Y Liang, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Hospital Avoidance Strategies for ABSSSI

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