Overview

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

Status:
Completed
Trial end date:
2018-10-30
Target enrollment:
0
Participant gender:
All
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)
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Allergan
Treatments:
Dalbavancin
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.