Back to resultsDevelopment of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Primary Purpose
Bacterial Infections, Acute Bacterial Skin and Skin Structure Infection
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dalbavancin
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Infections focused on measuring 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)
Eligibility Criteria
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.
Sites / Locations
- Weill Cornell Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
New Critical Pathway
Usual Care
Arm Description
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.
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
Outcomes
Primary Outcome Measures
Number of Infection-related Total Admitted Hospital Days
Secondary Outcome Measures
Number of Total Admitted Hospital Days
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time
Number of Participants With Infection-related Hospitalizations
Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit
Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital
Number of Participants With Infection-related Emergency Department (ED) Visits
Number of Participants With Infection-related Outpatient Healthcare Visits
Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy
Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy
Change From Baseline in Response to Treatment at End of Treatment Visit
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)
Patient Satisfaction With Care: Overall Health
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
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.
Patient Satisfaction With Care: Hospitalization
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
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.
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).
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).
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.
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).
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).
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).
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy
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
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
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
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
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Find Value in a Physician
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
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.
Healthcare Costs
Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03233438
Brief Title
Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Official Title
Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 24, 2017 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections, Acute Bacterial Skin and Skin Structure Infection
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)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
New Critical Pathway
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
Intervention Type
Drug
Intervention Name(s)
Dalbavancin
Other Intervention Name(s)
Dalvance®
Intervention Description
Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
Intervention Type
Drug
Intervention Name(s)
Usual Care
Intervention Description
Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
Primary Outcome Measure Information:
Title
Number of Infection-related Total Admitted Hospital Days
Time Frame
44 Days
Secondary Outcome Measure Information:
Title
Number of Total Admitted Hospital Days
Time Frame
44 Days
Title
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time
Time Frame
44 Days
Title
Number of Participants With Infection-related Hospitalizations
Time Frame
44 Days
Title
Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit
Time Frame
44 Days
Title
Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital
Time Frame
Follow-up: 30 Days
Title
Number of Participants With Infection-related Emergency Department (ED) Visits
Time Frame
44 Days
Title
Number of Participants With Infection-related Outpatient Healthcare Visits
Time Frame
44 Days
Title
Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy
Time Frame
44 Days
Title
Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy
Time Frame
44 Days
Title
Change From Baseline in Response to Treatment at End of Treatment Visit
Description
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
Time Frame
Baseline, Day 14
Title
Number of Participants With Serious Adverse Events (SAEs)
Time Frame
44 Days
Title
Patient Satisfaction With Care: Overall Health
Description
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame
14 Days
Title
Patient Satisfaction With Care: Wait in Emergency Room
Description
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Time Frame
14 Days
Title
Patient Satisfaction With Care: Hospitalization
Description
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame
14 Days
Title
Patient Satisfaction With Care: Satisfaction With Hospital Stay
Description
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Time Frame
14 Days
Title
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
Description
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame
14 Days
Title
Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections
Description
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame
14 Days
Title
Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy
Description
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Time Frame
14 Days
Title
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
Description
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame
14 Days
Title
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Description
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame
14 Days
Title
Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living
Description
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame
14 Days
Title
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy
Description
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame
14 Days
Title
Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day
Description
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Time Frame
14 Days
Title
Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV
Description
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Time Frame
14 Days
Title
Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV
Description
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame
14 Days
Title
Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV
Description
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame
14 Days
Title
Patient Satisfaction With Care: Find Value in a Physician
Description
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time Frame
14 Days
Title
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire
Time Frame
Day 10-14
Title
Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire
Description
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
Title
Healthcare Costs
Description
Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests
Time Frame
44 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Gillard
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31713130
Citation
McCarthy MW, Keyloun KR, Gillard P, Choi JJ, Pickell N, Copp R, Walsh TJ. Dalbavancin Reduces Hospital Stay and Improves Productivity for Patients with Acute Bacterial Skin and Skin Structure Infections: The ENHANCE Trial. Infect Dis Ther. 2020 Mar;9(1):53-67. doi: 10.1007/s40121-019-00275-4. Epub 2019 Nov 11.
Results Reference
derived
Links:
URL
http://AllerganClinicalTrials.com
Description
Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.
Learn more about this trial
Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
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