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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

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

NCT ID

NCT03372941

First Posted

December 4, 2017

Last Updated

November 11, 2022

Sponsor

Washington University School of Medicine

Collaborators

The Foundation for Barnes-Jewish Hospital, Allergan

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

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

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

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

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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