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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-24

Study Completion Date

2018-10-30

Brief Summary

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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)

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Detailed Description

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Conditions

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Bacterial Infections Acute Bacterial Skin and Skin Structure Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Dalbavancin

Intervention Type DRUG

Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.

Usual Care

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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type DRUG

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

Interventions

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Dalbavancin

Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.

Intervention Type DRUG

Usual Care

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

Intervention Type DRUG

Other Intervention Names

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Dalvance®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No