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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03372941
Other study ID # 201709136
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date March 4, 2019
Est. completion date October 14, 2021

Study information

Verified date November 2022
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

More than 40% of patients presenting with acute bacterial skin and skin structure infection (ABSSSI) to the Barnes-Jewish Hospital (BJH) emergency department (ED) are admitted for intravenous antibiotics. There is growing evidence to suggest that many hospital admissions for uncomplicated ABSSSI due to Gram-positive bacteria could be avoided with an alternative treatment strategy employing newer long-acting antibiotics. Coupled with close outpatient follow-up, such an alternative hospital avoidance strategy has the potential to improve quality and value of care for patients with uncomplicated ABSSSI and optimize use of limited inpatient healthcare resources.


Description:

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Study Design


Intervention

Drug:
Dalbavancin
Dalbavancin, a lipoglycopeptide antibiotic, has been approved by the FDA for the treatment of ABSSSI caused by Gram-positive bacteria. A single dose of dalbavancin will be administered in the Emergency Department followed by discharge with close outpatient infectious disease clinic follow-up.

Locations

Country Name City State
United States Barnes-Jewish Hospital Saint Louis Missouri

Sponsors (3)

Lead Sponsor Collaborator
Washington University School of Medicine Allergan, The Foundation for Barnes-Jewish Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Healthcare Utilization Related to ABSSSI Repeat ED visit(s) within 28 days, need for hospital admission(s) to receive intravenous antibiotics ("alternative treatment strategy" arm), or need for switch to different oral or intravenous antibiotic to treat ABSSSI ("usual care" arm) 28 days
Secondary Healthcare Cost Related to ABSSSI Management Indirect/direct costs associated with ED visit(s), indirect/direct costs associated with hospital admission(s) 28 days
Secondary Clinical Response Change in ABSSSI lesion area (cm2) 28 days
Secondary Clinical Success Clinical resolution of symptoms, need for additional intravenous/oral antibiotic therapy 28 days
Secondary Overall Patient Satisfaction Based on Standardized Measures Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey items 28 days
Secondary Patient Satisfaction Specific to ABSSSI Care Targeted survey questions specific to ABSSSI and patient-centered outcomes with relation to alternative treatment strategy vs. usual care 28 days
Secondary Patient Safety Adverse drug events 28 days
Secondary Quality of Life Measured Using RAND SF-36 Survey RAND SF-36 28 days
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