Weill Cornell Medicine
New York, 10065, United States
Completed
NCT Number: NCT03233438
Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
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)
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Dalbavancin
DrugDalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
Other names: Dalvance®
Usual Care
DrugUsual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
Primary outcomes
-
Number of Infection-related Total Admitted Hospital Days
Time frame: 44 Days
Secondary outcomes
-
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
-
Change From Baseline in Response to Treatment at End of Treatment Visit
Time frame: Baseline, Day 14
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)
Time frame: 44 Days
-
Patient Satisfaction With Care: Overall Health
Time frame: 14 Days
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
-
Patient Satisfaction With Care: Wait in Emergency Room
Time frame: 14 Days
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
Time frame: 14 Days
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
-
Patient Satisfaction With Care: Satisfaction With Hospital Stay
Time frame: 14 Days
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
Time frame: 14 Days
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
Time frame: 14 Days
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
-
Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy
Time frame: 14 Days
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
Time frame: 14 Days
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
Time frame: 14 Days
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
Time frame: 14 Days
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
-
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy
Time frame: 14 Days
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
Time frame: 14 Days
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
Time frame: 14 Days
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
Time frame: 14 Days
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
Time frame: 14 Days
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
-
Patient Satisfaction With Care: Find Value in a Physician
Time frame: 14 Days
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
Time frame: Day 10-14
-
Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire
Time frame: Day 14
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
Time frame: 44 Days
Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests
Sponsors and collaborators
Lead sponsor
Allergan
Industry
Registry information
Official study title
Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections
Important dates
- Study start
- 2017
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Jul 28, 2017
- Registry last updated
- Jan 18, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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