Development 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 Infection; Bacterial Infections

Treatments: Drug: Dalbavancin; Drug: Usual Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT03233438

CMO-US-ID-0528

Details and patient eligibility

About

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)

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

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

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