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

Bacterial Infections Clinical Trial

Official title:

Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03233438
• Other study ID #: CMO-US-ID-0528
• Status: Completed
• Phase: Phase 4
• Start date: July 24, 2017
• Est. completion date: October 30, 2018

Study information

• Verified date: January 2020
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: October 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Bacterial Skin and Skin Structure Infection
• Bacterial Infections
• Communicable Diseases
• Infection
• Skin Diseases, Bacterial

Intervention

Drug:
• Dalbavancin
Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
• Usual Care
Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Infection-related Total Admitted Hospital Days		44 Days
Secondary	Number of Total Admitted Hospital Days		44 Days
Secondary	Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time		44 Days
Secondary	Number of Participants With Infection-related Hospitalizations		44 Days
Secondary	Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit		44 Days
Secondary	Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital		Follow-up: 30 Days
Secondary	Number of Participants With Infection-related Emergency Department (ED) Visits		44 Days
Secondary	Number of Participants With Infection-related Outpatient Healthcare Visits		44 Days
Secondary	Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy		44 Days
Secondary	Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy		44 Days
Secondary	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	Baseline, Day 14
Secondary	Number of Participants With Serious Adverse Events (SAEs)		44 Days
Secondary	Patient Satisfaction With Care: Overall Health	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	14 Days
Secondary	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.	14 Days
Secondary	Patient Satisfaction With Care: Hospitalization	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	14 Days
Secondary	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.	14 Days
Secondary	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).	14 Days
Secondary	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).	14 Days
Secondary	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.	14 Days
Secondary	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).	14 Days
Secondary	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
Secondary	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).	14 Days
Secondary	Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	14 Days
Secondary	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.	14 Days
Secondary	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.	14 Days
Secondary	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).	14 Days
Secondary	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).	14 Days
Secondary	Patient Satisfaction With Care: Find Value in a Physician	Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).	14 Days
Secondary	Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire		Day 10-14
Secondary	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
Secondary	Healthcare Costs	Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests	44 Days

External Links

•   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.