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Hospital Avoidance Strategies for ABSSSI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03372941
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : August 4, 2020
Barnes-Jewish Hospital
Information provided by (Responsible Party):
Stephen Liang, Washington University School of Medicine

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dalbavancin

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).

Primary Outcome Measures :
  1. Healthcare utilization related to ABSSSI [ Time Frame: 28 days ]
    Repeat ED visit(s), need for hospital admission(s) to receive intravenous antibiotics (excluding initial hospital admission in "usual care" arm), need for switch to a different oral or intravenous antibiotic to treat ABSSSI

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03372941

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Contact: Stephen Y Liang, MD (314) 747-0750
Contact: Stacey House, MD, PhD (314) 747-4156

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United States, Missouri
Barnes-Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Stephen Liang         
Principal Investigator: Stephen Liang         
Sponsors and Collaborators
Washington University School of Medicine
Barnes-Jewish Hospital
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Principal Investigator: Stephen Y Liang, MD Washington University School of Medicine
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Responsible Party: Stephen Liang, Principal investigator, Washington University School of Medicine Identifier: NCT03372941    
Other Study ID Numbers: 201709136
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Emergency department
Additional relevant MeSH terms:
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Skin Diseases, Infectious
Connective Tissue Diseases
Pathologic Processes
Skin Diseases
Anti-Bacterial Agents
Anti-Infective Agents