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)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
91
Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
Weill Cornell Medicine
New York, New York, United States
Number of Infection-related Total Admitted Hospital Days
Time frame: 44 Days
Number of Total Admitted Hospital Days
Time frame: 44 Days
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time
Time frame: 44 Days
Number of Participants With Infection-related Hospitalizations
Time frame: 44 Days
Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit
Time frame: 44 Days
Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital
Time frame: Follow-up: 30 Days
Number of Participants With Infection-related Emergency Department (ED) Visits
Time frame: 44 Days
Number of Participants With Infection-related Outpatient Healthcare Visits
Time frame: 44 Days
Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy
Time frame: 44 Days
Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy
Time frame: 44 Days
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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
Time frame: Baseline, Day 14
Number of Participants With Serious Adverse Events (SAEs)
Time frame: 44 Days
Patient Satisfaction With Care: Overall Health
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time frame: 14 Days
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.
Time frame: 14 Days
Patient Satisfaction With Care: Hospitalization
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time frame: 14 Days
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.
Time frame: 14 Days
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).
Time frame: 14 Days
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).
Time frame: 14 Days
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.
Time frame: 14 Days
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).
Time frame: 14 Days
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).
Time frame: 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).
Time frame: 14 Days
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time frame: 14 Days
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.
Time frame: 14 Days
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.
Time frame: 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).
Time frame: 14 Days
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).
Time frame: 14 Days
Patient Satisfaction With Care: Find Value in a Physician
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time frame: 14 Days
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire
Time frame: Day 10-14
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.
Time frame: Day 14
Healthcare Costs
Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests
Time frame: 44 Days