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

Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections

The purpose of this study is to assess the effect of a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) compared to usual care for the treatment of ABSSI (Acute Bacterial Skin and Skin Structure Infections)

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine

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:

• Admitted patients who 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
Number of Infection-related Total Admitted Hospital Days	44 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Factors Contributing to Dissatisfaction With Receiving IV	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	14 Days
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
Number of Total Admitted Hospital Days		44 Days
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time		44 Days
Number of Participants With Infection-related Hospitalizations		44 Days
Number of Participants With Infection-related Hospitalizations 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		Follow-up: 30 Days
Change From Baseline in Response to Treatment at End of Treatment Visit	Response to treatment (healthcare provider assessment) comparing response at the Day 14 visit. Response to treatment will be defined through an assessment of erythema (measurement of lesion characteristics) and the absence of fever	Baseline, Day 14
Patient Satisfaction With Care: Overall Health	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	14 Days
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.	14 Days
Patient Satisfaction With Care: Hospitalization	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	14 Days
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.	14 Days
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).	14 Days
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).	14 Days
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.	14 Days
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).	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).	14 Days
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	14 Days
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.	14 Days
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.	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).	14 Days
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).	14 Days
Patient Satisfaction With Care: Find Value in a Physician	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	14 Days
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire		Day 10-14
Healthcare Costs	Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests	44 Days

Collaborators and Investigators

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

Publications and helpful links

General Publications

• McCarthy MW, Keyloun KR, Gillard P, Choi JJ, Pickell N, Copp R, Walsh TJ. Dalbavancin Reduces Hospital Stay and Improves Productivity for Patients with Acute Bacterial Skin and Skin Structure Infections: The ENHANCE Trial. Infect Dis Ther. 2020 Mar;9(1):53-67. doi: 10.1007/s40121-019-00275-4. Epub 2019 Nov 11.

Helpful Links

• Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2017
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 28, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 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 and Mycoses; Skin Diseases, Infectious; Infections; Communicable Diseases; Bacterial Infections; Skin Diseases, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Dalbavancin
• Other Study ID Numbers: CMO-US-ID-0528

Drug and device information, study documents

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