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

Phase 4

Completed

Conditions: Acute Bacterial Skin and Skin Structure Infection
Bacterial Infections

Interventions: Drug: Usual Care
Drug: Dalbavancin

Registration Number: NCT03233438

Lead Sponsor: Allergan

Brief Summary: 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)

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 91

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
New Critical Pathway	Dalbavancin	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.

Primary Outcome Measures

Name	Time	Method
Number of Infection-related Total Admitted Hospital Days	44 Days

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Infection-related Hospitalizations	44 Days
Number of Participants With Infection-related Emergency Department (ED) 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
Patient Satisfaction With Care: Hospitalization	14 Days	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Number of Total Admitted Hospital Days	44 Days
Patient Satisfaction With Care: Satisfaction With Hospital Stay	14 Days	Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy	14 Days	Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV	14 Days	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV	14 Days	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living	14 Days	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy	14 Days	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time	44 Days
Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital	Follow-up: 30 Days
Patient Satisfaction With Care: Overall Health	14 Days	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Wait in Emergency Room	14 Days	Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections	14 Days	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV	14 Days	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit	44 Days
Number of Participants With Infection-related Outpatient Healthcare Visits	44 Days
Change From Baseline in Response to Treatment at End of Treatment Visit	Baseline, Day 14	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
Number of Participants With Serious Adverse Events (SAEs)	44 Days
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay	14 Days	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire	Day 10-14
Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV	14 Days	Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Healthcare Costs	44 Days	Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests
Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day	14 Days	Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV	14 Days	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Find Value in a Physician	14 Days	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire	Day 14	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.