Clinical trial NCT03233438: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: 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)
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2017-07-28
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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.

Primary outcomes:
measure: Number of Infection-related Total Admitted Hospital Days
timeFrame: 44 Days
Secondary outcomes:
measure: Number of Total Admitted Hospital Days
timeFrame: 44 Days
measure: Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time
timeFrame: 44 Days
measure: Number of Participants With Infection-related Hospitalizations
timeFrame: 44 Days
measure: Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit
timeFrame: 44 Days
measure: Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital
timeFrame: Follow-up: 30 Days
measure: Number of Participants With Infection-related Emergency Department (ED) Visits
timeFrame: 44 Days
measure: Number of Participants With Infection-related Outpatient Healthcare Visits
timeFrame: 44 Days
measure: Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy
timeFrame: 44 Days
measure: Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy
timeFrame: 44 Days
measure: Change From Baseline in Response to Treatment at End of Treatment Visit
timeFrame: Baseline, Day 14
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: 44 Days
measure: Patient Satisfaction With Care: Overall Health
timeFrame: 14 Days
measure: Patient Satisfaction With Care: Wait in Emergency Room
timeFrame: 14 Days
measure: Patient Satisfaction With Care: Hospitalization
timeFrame: 14 Days
measure: Patient Satisfaction With Care: Satisfaction With Hospital Stay
timeFrame: 14 Days
measure: Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
timeFrame: 14 Days
measure: Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections
timeFrame: 14 Days
measure: Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy
timeFrame: 14 Days
measure: Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
timeFrame: 14 Days
measure: Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
timeFrame: 14 Days
measure: Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living
timeFrame: 14 Days
measure: Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy
timeFrame: 14 Days
measure: Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day
timeFrame: 14 Days
measure: Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV
timeFrame: 14 Days
measure: Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV
timeFrame: 14 Days
measure: Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV
timeFrame: 14 Days
measure: Patient Satisfaction With Care: Find Value in a Physician
timeFrame: 14 Days
measure: Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire
timeFrame: Day 10-14
measure: Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire
timeFrame: Day 14
measure: Healthcare Costs
timeFrame: 44 Days
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Allergan
name: Patrick Gillard
role: STUDY_DIRECTOR
References:
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.