Hospital Avoidance Strategies for ABSSSI
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|ClinicalTrials.gov Identifier: NCT03372941|
Recruitment Status : Not yet recruiting
First Posted : December 14, 2017
Last Update Posted : October 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Skin Infection||Drug: Dalbavancin||Phase 4|
This study seeks to establish the feasibility and acceptability of an alternative treatment strategy for uncomplicated acute bacterial skin and skin structure infection (ABSSSI) in the Barnes Jewish Hospital (BJH) Emergency Department (ED) focusing on hospital admission avoidance using single-dose, long-acting antimicrobial therapy complemented by close follow-up in the ambulatory setting. The extended half-life of these new antimicrobials (dalbavancin, oritavancin) allows for an effective treatment course of >7 days with a single dose, which is the accepted duration for which ABSSSI is usually treated with daily doses of other intravenous or oral antimicrobials. The investigators believe that such an approach will conserve hospital resources by reducing admissions for uncomplicated ABSSSI while delivering comparable if not superior care for this disease, allowing optimal utilization of BJH inpatient beds for other serious medical conditions requiring inpatient care. The investigators believe this novel alternative approach will allow hospitals such as BJH to more cost-effectively and efficiently manage ABSSSI patients. This study will reduce the number of >2 midnight observation admissions to BJH for ABSSSI, thereby improving inpatient capacity to care for patients requiring >2 midnight hospital inpatient admission.
The investigators will conduct a randomized controlled trial comparing patients treated with a single-dose of intravenous dalbavancin (an antibiotic that has been FDA-approved for the treatment of ABSSSI and is currently being used in clinical practice in the U.S.) and discharged home from the ED with close ambulatory care follow-up in clinic vs. patients treated with "usual care" (hospital admission for multiple doses of intravenous vancomycin or other antibiotic directed towards Gram-positive bacteria). Clinical outcomes, healthcare utilization, hospital costs, and patient satisfaction will be evaluated.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
This study will be single center, randomized, non-blinded study comparing two active treatment arms to treat uncomplicated ABSSSI suspected to be due to Gram-positive bacteria:
|Masking:||None (Open Label)|
|Official Title:||Hospital Avoidance Strategies for Treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI)|
|Estimated Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
Active Comparator: Alternative treatment strategy
Patient will receive a single dose of dalbavancin administered in the BJH ED or ED observation unit for ABSSSI followed by discharge w/ close Infectious Disease outpatient clinic follow-up.
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.
Other Name: Dalvance
No Intervention: Usual care
Patients will receive "usual care" (i.e., hospital admission for intravenous antibiotics - typically, vancomycin) - antibiotic and doses to be determined at the discretion of the treating clinician (both in the BJH ED and on the BJH inpatient ward).
- Healthcare utilization related to ABSSSI [ Time Frame: 28 days ]Repeat ED visit(s), need for hospital admission(s) to receive intravenous antibiotics (excluding initial hospital admission in "usual care" arm), need for switch to a different oral or intravenous antibiotic to treat ABSSSI
- Healthcare cost related to ABSSSI management [ Time Frame: 28 days ]Indirect/direct costs associated with ED visit(s), indirect/direct costs associated with hospital admission(s)
- Clinical response [ Time Frame: 28 days ]Change in ABSSSI lesion area (cm2)
- Clinical success [ Time Frame: 28 days ]Clinical resolution of symptoms, need for additional intravenous/oral antibiotic therapy
- Overall patient satisfaction based on standardized measures [ Time Frame: 28 days ]Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey items
- Patient satisfaction specific to ABSSSI care [ Time Frame: 28 days ]Targeted survey questions specific to ABSSSI and patient-centered outcomes with relation to alternative treatment strategy vs. usual care
- Patient safety [ Time Frame: 28 days ]Adverse drug events
- Quality of life measured using RAND SF-36 Survey [ Time Frame: 28 days ]RAND SF-36
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372941
|Contact: Stephen Y Liang, MD||(314) firstname.lastname@example.org|
|Contact: Stacey House, MD, PhD||(314) 747-4156|
|Principal Investigator:||Stephen Y Liang, MD||Washington University School of Medicine|