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

Acute Bacterial Skin and Skin Structure Infections Clinical Trial

Official title:

A Pragmatic Trial Designed to Evaluate a New Critical Pathway for Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02961764
• Other study ID #: CMO-US-ID-0476
• Status: Completed
• Phase: Phase 4
• Start date: November 29, 2016
• Est. completion date: March 29, 2019

Study information

• Verified date: March 2020
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: March 29, 2019
• Est. primary completion date: March 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Bacterial Skin and Skin Structure Infections
• Communicable Diseases
• Infection
• Skin Diseases, Bacterial

Intervention

Drug:
• Usual Care
Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
• Dalbavancin
Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Rush University Medical Center	Chicago	Illinois
United States	Henry Ford Hospital	Detroit	Michigan
United States	Wayne State University	Detroit	Michigan
United States	Hartford Hospital	Hartford	Connecticut
United States	Truman Medical Centers	Kansas City	Missouri
United States	ProMedica Monroe Regional Hospital	Monroe	Michigan
United States	Maricopa Medical Center	Phoenix	Arizona
United States	Olive View-UCLA Medical Center	Sylmar	California
United States	Tampa General Hospital	Tampa	Florida
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Admission Rate at Initial Episode of Care		44 Days
Secondary	Number of Total Admitted Hospital Days	Number of days during the initial hospitalization (for those initially hospitalized) and all other hospitalizations	44 Days
Secondary	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)	Initial Care: 14 Days
Secondary	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	44 Days
Secondary	Number of Infection-related Total Admitted Hospital Days		44 Days
Secondary	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	44 Days
Secondary	Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up That Resulted in Admission to Intensive Care Unit		44 Days
Secondary	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
Secondary	Number of Participants With Infection-related Emergency Department (ED) Visits		44 Days
Secondary	Number of Participants With Infection-related Outpatient Healthcare Visits		44 Days
Secondary	Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy		44 Days
Secondary	Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy		44 Days
Secondary	Number of Participants With Serious Adverse Events (SAEs)		44 Days
Secondary	Patient Satisfaction With Care: Overall Health	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	Day 14
Secondary	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.	Day 14
Secondary	Patient Satisfaction With Care: Hospitalization	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	Day 14
Secondary	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.	Day 14
Secondary	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).	Day 14
Secondary	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).	Day 14
Secondary	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.	Day 14
Secondary	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).	Day 14
Secondary	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
Secondary	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).	Day 14
Secondary	Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	Day 14
Secondary	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.	Day 14
Secondary	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.	Day 14
Secondary	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).	14 days
Secondary	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).	14 days
Secondary	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).	14 Days
Secondary	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).	14 Days
Secondary	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).	Day 14
Secondary	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).	Day 14
Secondary	Patient Satisfaction With Care: Find Value in a Physician	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	Day 14
Secondary	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	Day 14
Secondary	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

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