NCT03233438

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 18, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

July 26, 2017

Results QC Date

October 30, 2019

Last Update Submit

January 7, 2020

Conditions

Bacterial InfectionsAcute Bacterial Skin and Skin Structure Infection

Keywords

Critical PathwaysHealth FacilitiesClinical ProtocolsPatient SatisfactionAbsenteeismAnti-Bacterial AgentsQuality of LifeEconomics, MedicalHealth ResourcesHealth resource utilizationAcute bacterial skin and skin structure infection (ABSSSI)

Outcome Measures

Primary Outcomes (1)

  • Number of Infection-related Total Admitted Hospital Days

    44 Days

Secondary Outcomes (30)

  • Number of Total Admitted Hospital Days

    44 Days

  • Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time

    44 Days

  • Number of Participants With Infection-related Hospitalizations

    44 Days

  • Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit

    44 Days

  • Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital

    Follow-up: 30 Days

  • +25 more secondary outcomes

Study Arms (2)

New Critical Pathway

ACTIVE COMPARATOR

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.

Drug: Dalbavancin

Usual Care

ACTIVE COMPARATOR

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

Drug: Usual Care

Interventions

DalbavancinDRUG

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

Also known as: Dalvance®
New Critical Pathway
Usual CareDRUG

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

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted patients who 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (1)

  • McCarthy MW, Keyloun KR, Gillard P, Choi JJ, Pickell N, Copp R, Walsh TJ. Dalbavancin Reduces Hospital Stay and Improves Productivity for Patients with Acute Bacterial Skin and Skin Structure Infections: The ENHANCE Trial. Infect Dis Ther. 2020 Mar;9(1):53-67. doi: 10.1007/s40121-019-00275-4. Epub 2019 Nov 11.

    PMID: 31713130DERIVED

Related Links

MeSH Terms

Conditions

Bacterial InfectionsPatient Satisfaction

Interventions

dalbavancin

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Therapeutic Area, Head
Organization
Allergan
IR-CTRegistration@allergan.com
714-246-4500

Study Officials

  • Patrick Gillard

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2017

First Posted

July 28, 2017

Study Start

July 24, 2017

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

January 18, 2020

Results First Posted

January 18, 2020

Record last verified: 2020-01

Locations

US(1)