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

Allergan313 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

313

Conditions

Acute Bacterial Skin and Skin Structure Infections

Interventions

Usual CareDRUG

Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.

DalbavancinDRUG

Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Maricopa Medical Center

Phoenix, Arizona, United States

Olive View-UCLA Medical Center

Sylmar, California, United States

Hartford Hospital

Hartford, Connecticut, United States

Outcomes

Primary Outcomes

Hospital Admission Rate at Initial Episode of Care

Time frame: 44 Days

Secondary Outcomes

Number of Total Admitted Hospital Days

Number of days during the initial hospitalization (for those initially hospitalized) and all other hospitalizations

Time frame: 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)

Time frame: 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

Time frame: 44 Days

Number of Infection-related Total Admitted Hospital Days

Time frame: 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

Time frame: 44 Days

Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up That Resulted in Admission to Intensive Care Unit

Time frame: 44 Days

Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED

Data from ClinicalTrials.gov

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Tampa General Hospital

Tampa, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

University of Massachusetts

Worcester, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Wayne State University

Detroit, Michigan, United States

ProMedica Monroe Regional Hospital

Monroe, Michigan, United States

...and 1 more locations

Time frame: Follow-up: 30 Days

Number of Participants With Infection-related Emergency Department (ED) Visits

Time frame: 44 Days

Number of Participants With Infection-related Outpatient Healthcare Visits

Time frame: 44 Days

Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy

Time frame: 44 Days

Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy

Time frame: 44 Days

Number of Participants With Serious Adverse Events (SAEs)

Time frame: 44 Days

Patient Satisfaction With Care: Overall Health

Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

Time frame: 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.

Time frame: Day 14

Patient Satisfaction With Care: Hospitalization

Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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

Time frame: 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.

Time frame: Day 14