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

Completed · Phase 4

Conditions studied: Acute Bacterial Skin and Skin Structure Infections

In brief

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.

Key facts

Study ID

NCT02961764

Run by

Allergan

People needed

313

Starts

2016-11-29

Expected to finish

2019-03-29

Last updated by the study team

2020-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Maricopa Medical Center — Phoenix, Arizona, United States
• Olive View-UCLA Medical Center — Sylmar, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Tampa General Hospital — Tampa, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Wayne State University — Detroit, Michigan, United States
• ProMedica Monroe Regional Hospital — Monroe, Michigan, United States
• Truman Medical Centers — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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