Clinical trial NCT02961764: Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Official title: A Pragmatic Trial Designed to Evaluate a New Critical Pathway for Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Bacterial Skin and Skin Structure Infections
Keywords: Critical Pathways
Health Facilities
Clinical Protocols
Patient Satisfaction
Absenteeism
Anti-Bacterial Agents
Quality of Life
Economics, Medical
Health Resources
Health resource utilization
Acute bacterial skin and skin structure infection (ABSSSI)
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-11-11
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hospital Admission Rate at Initial Episode of Care
timeFrame: 44 Days
Secondary outcomes:
measure: Number of Total Admitted Hospital Days
timeFrame: 44 Days
measure: Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care
timeFrame: Initial Care: 14 Days
measure: Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time
timeFrame: 44 Days
measure: Number of Infection-related Total Admitted Hospital Days
timeFrame: 44 Days
measure: Number of Participants With Infection-related Hospitalizations
timeFrame: 44 Days
measure: Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up That Resulted in Admission to Intensive Care Unit
timeFrame: 44 Days
measure: Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED
timeFrame: Follow-up: 30 Days
measure: Number of Participants With Infection-related Emergency Department (ED) Visits
timeFrame: 44 Days
measure: Number of Participants With Infection-related Outpatient Healthcare Visits
timeFrame: 44 Days
measure: Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy
timeFrame: 44 Days
measure: Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy
timeFrame: 44 Days
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: 44 Days
measure: Patient Satisfaction With Care: Overall Health
timeFrame: Day 14
measure: Patient Satisfaction With Care: Wait in Emergency Room
timeFrame: Day 14
measure: Patient Satisfaction With Care: Hospitalization
timeFrame: Day 14
measure: Patient Satisfaction With Care: Satisfaction With Hospital Stay
timeFrame: Day 14
measure: Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
timeFrame: Day 14
measure: Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections
timeFrame: Day 14
measure: Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy
timeFrame: Day 14
measure: Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
timeFrame: Day 14
measure: Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
timeFrame: 14 Days
measure: Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living
timeFrame: Day 14
measure: Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy
timeFrame: Day 14
measure: Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day
timeFrame: Day 14
measure: Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV
timeFrame: Day 14
measure: Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV
timeFrame: 14 days
measure: Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider
timeFrame: 14 days
measure: Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV
timeFrame: 14 Days
measure: Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care
timeFrame: 14 Days
measure: Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV
timeFrame: Day 14
measure: Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV
timeFrame: Day 14
measure: Patient Satisfaction With Care: Find Value in a Physician
timeFrame: Day 14
measure: Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire
timeFrame: Day 14
measure: Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire
timeFrame: Day 14
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Medical Center
state: Arizona
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Monroe
country: United States
facility: ProMedica Monroe Regional Hospital
state: Michigan
city: Kansas City
country: United States
facility: Truman Medical Centers
state: Missouri
Study officials:
affiliation: Allergan
name: Patrick Gillard
role: STUDY_DIRECTOR
References:
citation: 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.