Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

A Pragmatic Trial Designed to Evaluate a New Critical Pathway for Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections

This study will evaluate a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) for the treatment of ABSSSI compared to usual care.

Study Overview

• Status: Completed
• Conditions: Acute Bacterial Skin and Skin Structure Infections
• Intervention / Treatment: Drug: Usual Care; Drug: Dalbavancin

• Study Type: Interventional
• Enrollment (Actual): 313
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Maricopa Medical Center
  • California
    • Sylmar, California, United States, 91342
      • Olive View-UCLA Medical Center
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48202
      • Wayne State University
    • Monroe, Michigan, United States, 48162
      • ProMedica Monroe Regional Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Truman Medical Centers

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Presents to the Emergency Department (ED) and meets the clinical definition for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
• Known or suspected gram-positive infection.

Exclusion Criteria:

• Known or suspected gram-negative infections, anaerobic infections, or fungemia
• Known or suspected infections that are severe, life threatening or are not included in the ABSSSI Food and Drug Administration (FDA) guidance
• Injection drug users with a fever
• Severe neurological disorder leading to immobility or confined to a wheelchair
• Bilateral Lower extremity involvement of the suspected infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.	Drug: Usual Care; Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
Active Comparator: New Critical Pathway; The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.	Drug: Dalbavancin; Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.; Other Names: Dalvance®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospital Admission Rate at Initial Episode of Care	44 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Total Admitted Hospital Days	Number of days during the initial hospitalization (for those initially hospitalized) and all other hospitalizations	44 Days
Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care	Time spent in ED in hours from triage to release (either admitted to the hospital, admitted to observation, or released to home)	Initial Care: 14 Days
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time	Number of all major surgical interventions unexpected or expected that required operating room time	44 Days
Number of Infection-related Total Admitted Hospital Days		44 Days
Number of Participants With Infection-related Hospitalizations	Number of days of hospitalization during the initial hospitalization (for those initially hospitalized) and all other infection-related hospitalizations	44 Days
Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up That Resulted in Admission to Intensive Care Unit		44 Days
Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED		Follow-up: 30 Days
Number of Participants With Infection-related Emergency Department (ED) Visits		44 Days
Number of Participants With Infection-related Outpatient Healthcare Visits		44 Days
Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy		44 Days
Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy		44 Days
Number of Participants With Serious Adverse Events (SAEs)		44 Days
Patient Satisfaction With Care: Overall Health	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	Day 14
Patient Satisfaction With Care: Wait in Emergency Room	Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.	Day 14
Patient Satisfaction With Care: Hospitalization	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	Day 14
Patient Satisfaction With Care: Satisfaction With Hospital Stay	Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.	Day 14
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	Day 14
Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	Day 14
Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy	Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.	Day 14
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	Day 14
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	14 Days
Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	Day 14
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	Day 14
Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day	Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.	Day 14
Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV	Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.	Day 14
Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	14 days
Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	14 days
Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	14 Days
Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	14 Days
Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	Day 14
Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	Day 14
Patient Satisfaction With Care: Find Value in a Physician	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	Day 14
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire	Number of days with lost/reduced productivity during follow-up, as measured with Work Productivity and Activity Impairment (WPAI) Questionnaire	Day 14
Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire	The SF-12 yields a physical and a mental health component summary score (referred to as physical component summary score [PCS] and mental component summary score [MCS]). The PCS and MCS follow a t-score distribution, i.e. mean of 50 and standard deviation of 10 in the general US population, meaning all scores above or below 50 are above and below the average, respectively, in the US general population.	Day 14

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Patrick Gillard, Allergan

Publications and helpful links

General Publications

• Talan DA, Mower WR, Lovecchio FA, Rothman RE, Steele MT, Keyloun K, Gillard P, Copp R, Moran GJ. Pathway with single-dose long-acting intravenous antibiotic reduces emergency department hospitalizations of patients with skin infections. Acad Emerg Med. 2021 Oct;28(10):1108-1117. doi: 10.1111/acem.14258. Epub 2021 May 5.

Helpful Links

• More Information

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2016
• Primary Completion (Actual): March 29, 2019
• Study Completion (Actual): March 29, 2019

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: November 9, 2016
• First Posted (Estimate): November 11, 2016

Study Record Updates

• Last Update Posted (Actual): April 10, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Quality of Life; Health Facilities; Clinical Protocols; Patient Satisfaction; Critical Pathways; Absenteeism; Anti-Bacterial Agents; Economics, Medical; Health Resources; Health resource utilization; Acute bacterial skin and skin structure infection (ABSSSI)
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Infections; Communicable Diseases; Skin Diseases, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Dalbavancin
• Other Study ID Numbers: CMO-US-ID-0476

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No