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

Study Overview
=================
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.

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

Conditions
-----------------
Acute Bacterial Skin and Skin Structure Infections

Intervention / Treatment
-----------------
* Drug: Usual Care
* Drug: Dalbavancin


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI. | Drug: Usual Care<br>* Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.<br>|
| Active Comparator: New Critical Pathway<br>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. | Drug: Dalbavancin<br>* Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.<br>* Other names: Dalvance®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Admission Rate at Initial Episode of Care |  | 44 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Total Admitted Hospital Days | Number of days during the initial hospitalization (for those initially hospitalized) and all other hospitalizations | 44 Days | 
| 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 | 
| 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 | 
| Number of Infection-related Total Admitted Hospital Days |  | 44 Days | 
| 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 | 
| 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 All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED |  | Follow-up: 30 Days | 
| Number of Participants With Infection-related Emergency Department (ED) Visits |  | 44 Days | 
| Number of Participants With Infection-related Outpatient Healthcare 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 | 
| Number of Participants With Serious Adverse Events (SAEs) |  | 44 Days | 
| Patient Satisfaction With Care: Overall Health | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). | Day 14 | 
| 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 | 
| Patient Satisfaction With Care: Hospitalization | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). | Day 14 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life, Economics, Medical, Health Resources, Critical Pathways, Health Facilities, Clinical Protocols, Patient Satisfaction, Absenteeism, Anti-Bacterial Agents, Health resource utilization, Acute bacterial skin and skin structure infection (ABSSSI)