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

Allergan

Status and phase: Completed; Phase 4

Conditions: Acute Bacterial Skin and Skin Structure Infections

Treatments: Drug: Dalbavancin; Drug: Usual Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT02961764

CMO-US-ID-0476

Details and patient eligibility

About

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.

Enrollment: 313 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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313 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

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

Treatment:

Drug: Usual Care

New Critical Pathway

Active Comparator group

Description:

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.

Treatment:

Drug: Dalbavancin