Evaluation 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 Infections
• Interventions: Drug: Usual Care; Drug: Dalbavancin

• Registration Number: NCT02961764
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-11
• Study Start: 2016-11-29
• Primary Completion: 2019-03-29
• Study Completion: 2019-03-29
• Status Verified: 2020-03
• Results First Submitted: 2020-03-27
• Results First Submitted QC: 2020-03-27
• Last Update Submitted: 2020-03-27
• Results First Posted: 2020-04-10
• Last Update Posted: 2020-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

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 & 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
Hospital Admission Rate at Initial Episode of Care	44 Days

Secondary Outcome Measures

Name	Time	Method
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	Day 14	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay	Day 14	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).
Number of Participants With Infection-related Hospitalizations	44 Days	Number of days of hospitalization during the initial hospitalization (for those initially hospitalized) and all other infection-related hospitalizations
Patient Satisfaction With Care: Overall Health	Day 14	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day	Day 14	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: Time to Travel to Appointments to Receive IV	14 days	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV	14 Days	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Number of Infection-related Total Admitted Hospital Days	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 Infection-related Outpatient Healthcare Visits	44 Days
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV	Day 14	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	Day 14	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care	14 Days	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care	Initial Care: 14 Days	Time spent in ED in hours from triage to release (either admitted to the hospital, admitted to observation, or released to home)
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time	44 Days	Number of all major surgical interventions unexpected or expected that required operating room time
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 Serious Adverse Events (SAEs)	44 Days
Patient Satisfaction With Care: Wait in Emergency Room	Day 14	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	Day 14	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 the Average Time to Administer Each IV	Day 14	Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire	Day 14	Number of days with lost/reduced productivity during follow-up, as measured with Work Productivity and Activity Impairment (WPAI) Questionnaire
Number of Total Admitted Hospital Days	44 Days	Number of days during the initial hospitalization (for those initially hospitalized) and all other hospitalizations
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
Patient Satisfaction With Care: Satisfaction With Hospital Stay	Day 14	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	Day 14	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy	Day 14	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV	Day 14	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider	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	Day 14	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Find Value in a Physician	Day 14	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.

Trial Locations

Locations (11)

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

ProMedica Monroe Regional Hospital; 🇺🇸 Monroe, Michigan, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

University of Massachusetts; 🇺🇸 Worcester, Massachusetts, United States

Truman Medical Centers; 🇺🇸 Kansas City, Missouri, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Olive View-UCLA Medical Center; 🇺🇸 Sylmar, California, United States

Maricopa Medical Center; 🇺🇸 Phoenix, Arizona, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States