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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03233438
Recruitment Status : Completed
First Posted : July 28, 2017
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief 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)

Condition or disease Intervention/treatment Phase
Bacterial Infections Acute Bacterial Skin and Skin Structure Infection Drug: Dalbavancin Drug: Usual Care Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections
Actual Study Start Date : July 24, 2017
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dalbavancin

Arm Intervention/treatment
Active Comparator: New Critical Pathway
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
Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
Other Name: Dalvance®

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




Primary Outcome Measures :
  1. Number of Infection-related Total Admitted Hospital Days [ Time Frame: 44 Days ]

Secondary Outcome Measures :
  1. Number of Total Admitted Hospital Days [ Time Frame: 44 Days ]
  2. Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time [ Time Frame: 44 Days ]
  3. Number of Participants With Infection-related Hospitalizations [ Time Frame: 44 Days ]
  4. Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit [ Time Frame: 44 Days ]
  5. Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital [ Time Frame: Follow-up: 30 Days ]
  6. Number of Participants With Infection-related Emergency Department (ED) Visits [ Time Frame: 44 Days ]
  7. Number of Participants With Infection-related Outpatient Healthcare Visits [ Time Frame: 44 Days ]
  8. Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy [ Time Frame: 44 Days ]
  9. Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy [ Time Frame: 44 Days ]
  10. 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

  11. Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: 44 Days ]
  12. Patient Satisfaction With Care: Overall Health [ Time Frame: 14 Days ]
    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

  13. 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.

  14. Patient Satisfaction With Care: Hospitalization [ Time Frame: 14 Days ]
    Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

  15. 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.

  16. 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).

  17. 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).

  18. 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.

  19. 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).

  20. 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).

  21. 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).

  22. 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).

  23. 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.

  24. 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.

  25. 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).

  26. 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).

  27. 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).

  28. Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire [ Time Frame: Day 10-14 ]
  29. 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.

  30. Healthcare Costs [ Time Frame: 44 Days ]
    Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233438


Locations
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United States, New York
Weill Cornell Medicine
New York, New York, United States, 10065
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Patrick Gillard Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] March 3, 2017
Statistical Analysis Plan  [PDF] May 9, 2018


Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03233438    
Other Study ID Numbers: CMO-US-ID-0528
First Posted: July 28, 2017    Key Record Dates
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allergan:
Critical Pathways
Health Facilities
Clinical Protocols
Patient Satisfaction
Absenteeism
Anti-Bacterial Agents
Quality of Life
Economics, Medical
Health Resources
Health resource utilization
Acute bacterial skin and skin structure infection (ABSSSI)
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Skin Diseases
Dalbavancin
Anti-Bacterial Agents
Anti-Infective Agents