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Evaluation 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: NCT02961764
Recruitment Status : Completed
First Posted : November 11, 2016
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 322 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pragmatic Trial Designed to Evaluate a New Critical Pathway for Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections
Actual Study Start Date : November 29, 2016
Actual Primary Completion Date : March 27, 2019
Actual Study Completion Date : March 27, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dalbavancin

Arm Intervention/treatment
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.

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®




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

Secondary Outcome Measures :
  1. Number of Infection-related Total Admitted Hospital Days [ Time Frame: 44 Days ]
  2. Hospital Admission Rate at Initial Episode of Care [ Time Frame: Initial Care: 14 Days ]
  3. Emergency Department (ED) Length of Stay at Initial Episode of Care [ Time Frame: Initial Care: 14 Days ]
  4. Number of Infection-related Major Surgical Interventions that Required Operating Room Time [ Time Frame: 44 Days ]
  5. Number of Infection-related Hospitalizations [ Time Frame: 44 Days ]
  6. Number of Infection-related Hospitalizations during Initial Care and Follow-up that Resulted in Admission to Intensive Care Unit [ Time Frame: 44 Days ]
  7. Number of 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 Infection-related ED Visits [ Time Frame: 44 Days ]
  9. Number of 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 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 as Assessed by a 21-Item Questionnaire [ Time Frame: Day 14 ]
  14. Number of Days with Work and Productivity Loss Assessed by the 6-Item Work Productivity and Activity Impairment Specific Health Problem (WPAI:SHP) Questionnaire [ Time Frame: Day 14 ]
  15. Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire [ Time Frame: Day 14 ]


Information from the National Library of Medicine

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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:

  • 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.

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): NCT02961764


Locations
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United States, Arizona
Maricopa Medical Center
Phoenix, Arizona, United States, 85008
United States, California
Olive View-UCLA Medical Center
Sylmar, California, United States, 91342
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
University of Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Wayne State University
Detroit, Michigan, United States, 48202
ProMedica Monroe Regional Hospital
Monroe, Michigan, United States, 48162
United States, Missouri
Truman Medical Centers
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Patrick Gillard Allergan

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02961764     History of Changes
Other Study ID Numbers: CMO-US-ID-0476
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019

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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
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Skin Diseases
Dalbavancin
Anti-Bacterial Agents
Anti-Infective Agents