Trial Outcomes & Findings for Antimicrobial Stewardship Through MRSA Diagnosis in Emergency Department (ED) Patients With Abscesses (NCT NCT01523899)

Results Overview

Number of Participants with Antibiotic Usage at the time of the ED visit (narrow spectrum, broad spectrum, or none) will be recorded at the time of the ED visit

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

252 participants

Primary outcome timeframe

Baseline

Results posted on

2017-09-06

Participant Flow

Participant milestones

Participant milestones
Measure	Xpert MRSA/SA SSTI Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay	Standard Culture Standard bacterial culture and susceptibility testing
Overall Study STARTED	126	126
Overall Study COMPLETED	126	126
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antimicrobial Stewardship Through MRSA Diagnosis in Emergency Department (ED) Patients With Abscesses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Xpert MRSA/SA SSTI n=126 Participants Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay	Standard Culture n=126 Participants Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay	Total n=252 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	126 Participants n=99 Participants	126 Participants n=107 Participants	252 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	36 years STANDARD_DEVIATION 13.4 • n=99 Participants	36.5 years STANDARD_DEVIATION 13.8 • n=107 Participants	36 years STANDARD_DEVIATION 13.4 • n=206 Participants
Sex: Female, Male Female	63 Participants n=99 Participants	73 Participants n=107 Participants	136 Participants n=206 Participants
Sex: Female, Male Male	63 Participants n=99 Participants	53 Participants n=107 Participants	116 Participants n=206 Participants
Region of Enrollment United States	126 participants n=99 Participants	126 participants n=107 Participants	252 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline

Number of Participants with Antibiotic Usage at the time of the ED visit (narrow spectrum, broad spectrum, or none) will be recorded at the time of the ED visit

Outcome measures

Outcome measures
Measure	Xpert MRSA/SA SSTI n=126 Participants Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay	Standard Culture n=126 Participants Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
Number of Participants With Antibiotic Usage at the Time of the ED Visit	97 Participants	96 Participants

SECONDARY outcome

Timeframe: 2 to 7 days

clinical improvement (decreasing erythema, pain, swelling, drainage, and presence or absence of fever) will be documented at 2-7 day phone follow up and 1 and 3 months

Outcome measures

Outcome measures
Measure	Xpert MRSA/SA SSTI n=103 Participants Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay	Standard Culture n=103 Participants Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
Participant Clinical Improvement Post-treatment at One Week	91 Participants	94 Participants

SECONDARY outcome

Timeframe: 3 months

Recurrence of abscess within a three month time period

Outcome measures

Outcome measures
Measure	Xpert MRSA/SA SSTI n=91 Participants Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay	Standard Culture n=88 Participants Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
Clinical Outcome at One or Three Months	26 Participants	24 Participants

Adverse Events

Xpert MRSA/SA SSTI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Culture

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

Larissa May, MD

University of California-Davis

Phone: 9167345000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place