Hospital Avoidance Strategies for ABSSSI

• ClinicalTrials.gov Identifier: NCT03372941
• Recruitment Status: Terminated
• First Posted: December 14, 2017
• Results First Posted: December 9, 2022
• Last Update Posted: December 9, 2022
• Sponsor: Washington University School of Medicine
• Collaborators: The Foundation for Barnes-Jewish Hospital; Allergan
• Information provided by (Responsible Party): Stephen Liang, Washington University School of Medicine

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.

Condition or disease	Intervention/treatment	Phase
Skin Infection	Drug: Dalbavancin	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

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)

• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Hospital Avoidance Strategies for Treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
• Actual Study Start Date: March 4, 2019
• Actual Primary Completion Date: October 14, 2021
• Actual Study Completion Date: October 14, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Drug: 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.; Other Name: Dalvance
No Intervention: 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).

Outcome Measures

Primary Outcome Measures :

1. Healthcare Utilization Related to ABSSSI [ Time Frame: 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 Outcome Measures :

1. Healthcare Cost Related to ABSSSI Management [ Time Frame: 28 days ]
   Indirect/direct costs associated with ED visit(s), indirect/direct costs associated with hospital admission(s)
2. Clinical Response [ Time Frame: 28 days ]
   Change in ABSSSI lesion area (cm2)
3. Clinical Success [ Time Frame: 28 days ]
   Clinical resolution of symptoms, need for additional intravenous/oral antibiotic therapy
4. Overall Patient Satisfaction Based on Standardized Measures [ Time Frame: 28 days ]
   Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey items
5. Patient Satisfaction Specific to ABSSSI Care [ Time Frame: 28 days ]
   Targeted survey questions specific to ABSSSI and patient-centered outcomes with relation to alternative treatment strategy vs. usual care
6. Patient Safety [ Time Frame: 28 days ]
   Adverse drug events
7. Quality of Life Measured Using RAND SF-36 Survey [ Time Frame: 28 days ]
   RAND SF-36

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

  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

Contacts and Locations

Locations

United States, Missouri

Barnes-Jewish Hospital

Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

The Foundation for Barnes-Jewish Hospital

Allergan

Investigators

• Principal Investigator: Stephen Y Liang, MD; Washington University School of Medicine

  Study Documents (Full-Text)

Documents provided by Stephen Liang, Washington University School of Medicine:

Study Protocol and Statistical Analysis Plan  [PDF] May 28, 2019

More Information

• Responsible Party: Stephen Liang, Principal investigator, Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT03372941
• Other Study ID Numbers: 201709136
• First Posted: December 14, 2017
• Results First Posted: December 9, 2022
• Last Update Posted: December 9, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Keywords provided by Stephen Liang, Washington University School of Medicine:

Acute bacterial skin and skin structure infections; Hospital avoidance; Antibiotic therapy; Dalbavancin; Emergency department

Additional relevant MeSH terms:

Infections; Cellulitis; Skin Diseases, Infectious; Pathologic Processes; Suppuration; Connective Tissue Diseases; Inflammation; Skin Diseases; Dalbavancin; Anti-Bacterial Agents; Anti-Infective Agents