Trial Outcomes & Findings for Hospital Avoidance Strategies for ABSSSI (NCT NCT03372941)

NCT ID: NCT03372941

Last Updated: 2022-12-09

Results Overview

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)

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 11 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2022-12-09

Participant Flow

Participant milestones

Measure	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: 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.	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).
Overall Study STARTED	6	5
Overall Study COMPLETED	4	1
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Measure	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: 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.	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).
Overall Study Lost to Follow-up	2	4

Baseline Characteristics

Hospital Avoidance Strategies for ABSSSI

Baseline characteristics by cohort

Measure	Alternative Treatment Strategy n=6 Participants 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: 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.	Usual Care n=5 Participants 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).	Total n=11 Participants Total of all reporting groups
Age, Continuous	43.3 years n=93 Participants	42.4 years n=4 Participants	42.9 years n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: 28 days

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)

Outcome measures

Measure	Alternative Treatment Strategy n=6 Participants 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: 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.	Usual Care n=5 Participants 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 Number of participants with repeat ED visit	0 Participants	1 Participants
Healthcare Utilization Related to ABSSSI Number of participants with need for hospital admission(s) to receive IV antibiotics	1 Participants	0 Participants
Healthcare Utilization Related to ABSSSI Number of patients without additional healthcare utilization to treat ABSSSI	5 Participants	4 Participants
Healthcare Utilization Related to ABSSSI Number of participants with need for switch to different oral antibiotic	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Data were not collected

Indirect/direct costs associated with ED visit(s), indirect/direct costs associated with hospital admission(s)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: Data were not collected

Change in ABSSSI lesion area (cm2)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Clinical resolution of symptoms, need for additional intravenous/oral antibiotic therapy

Outcome measures

Measure	Alternative Treatment Strategy n=4 Participants 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: 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.	Usual Care n=1 Participants 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).
Clinical Success Number of participants with clinical resolution of symptoms	4 Participants	1 Participants
Clinical Success Number of participants with need for additional intravenous/oral antibiotic therapy	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Data were not collected

Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey items

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: Data were not collected

Targeted survey questions specific to ABSSSI and patient-centered outcomes with relation to alternative treatment strategy vs. usual care

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Adverse drug events

Outcome measures

Measure	Alternative Treatment Strategy n=4 Participants 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: 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.	Usual Care n=1 Participants 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).
Patient Safety Number of participants with an adverse drug event	0 Participants	0 Participants
Patient Safety Number of participants without an adverse drug event	4 Participants	1 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Data were not collected

RAND SF-36

Outcome measures

Outcome data not reported

Adverse Events

Alternative Treatment Strategy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephen Liang

Washington University School of Medicine

Phone: 3017470750

Email: syliang@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place