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Completed

NCT Number: NCT02961764

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

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.

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Key information

Conditions

Acute Bacterial Skin and Skin Structure Infections Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Maricopa Medical Center, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Usual Care

Drug

Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.

Dalbavancin

Drug

Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.

Other names: Dalvance®

Primary outcomes

  1. Hospital Admission Rate at Initial Episode of Care

    Time frame: 44 Days

Secondary outcomes

  1. Number of Total Admitted Hospital Days

    Time frame: 44 Days

    Number of days during the initial hospitalization (for those initially hospitalized) and all other hospitalizations

  2. Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care

    Time frame: Initial Care: 14 Days

    Time spent in ED in hours from triage to release (either admitted to the hospital, admitted to observation, or released to home)

  3. Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time

    Time frame: 44 Days

    Number of all major surgical interventions unexpected or expected that required operating room time

  4. Number of Infection-related Total Admitted Hospital Days

    Time frame: 44 Days

  5. Number of Participants With Infection-related Hospitalizations

    Time frame: 44 Days

    Number of days of hospitalization during the initial hospitalization (for those initially hospitalized) and all other infection-related hospitalizations

  6. Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up That Resulted in Admission to Intensive Care Unit

    Time frame: 44 Days

  7. Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED

    Time frame: Follow-up: 30 Days

  8. Number of Participants With Infection-related Emergency Department (ED) Visits

    Time frame: 44 Days

  9. Number of Participants With Infection-related Outpatient Healthcare Visits

    Time frame: 44 Days

  10. Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy

    Time frame: 44 Days

  11. Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy

    Time frame: 44 Days

  12. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: 44 Days

  13. Patient Satisfaction With Care: Overall Health

    Time frame: Day 14

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

  14. Patient Satisfaction With Care: Wait in Emergency Room

    Time frame: Day 14

    Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.

  15. Patient Satisfaction With Care: Hospitalization

    Time frame: Day 14

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

  16. Patient Satisfaction With Care: Satisfaction With Hospital Stay

    Time frame: Day 14

    Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.

  17. Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay

    Time frame: Day 14

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

  18. Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections

    Time frame: Day 14

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

  19. Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy

    Time frame: Day 14

    Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.

  20. Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV

    Time frame: Day 14

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

  21. 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).

  22. Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living

    Time frame: Day 14

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

  23. Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy

    Time frame: Day 14

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

  24. Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day

    Time frame: Day 14

    Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.

  25. Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV

    Time frame: Day 14

    Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.

  26. Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV

    Time frame: 14 days

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

  27. Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider

    Time frame: 14 days

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

  28. Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV

    Time frame: 14 Days

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

  29. Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care

    Time frame: 14 Days

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

  30. Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV

    Time frame: Day 14

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

  31. Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV

    Time frame: Day 14

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

  32. Patient Satisfaction With Care: Find Value in a Physician

    Time frame: Day 14

    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

  33. Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire

    Time frame: Day 14

    Number of days with lost/reduced productivity during follow-up, as measured with Work Productivity and Activity Impairment (WPAI) Questionnaire

  34. 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 11, 2016
Registry last updated
Apr 10, 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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