Cutaneous Abscess
Conditions
Keywords
SSTI, cutaneous abscess, boil
Brief summary
This study expands upon pilot data for feasibility since May 2011. The study aims to evaluate the effect of rapid test availability on use of targeted spectrum antibiotics for non-MRSA abscesses in ambulatory patients in the Emergency Department (ED). The multi-institutional study will assess the feasibility of providing the GeneXpert® MRSA/SA SSTI assay to the ED and evaluate the impact of delivering the test result to clinicians in real-time on patient management decisions regarding the use of antimicrobial agents. Patients are randomized to standard culture (control arm) or to the GeneXpert® assay plus standard culture.
Detailed description
Our objective was to determine whether real-time availability of rapid molecular results of Staphylococcus aureus would impact emergency department clinician antimicrobial selection for adults with cutaneous abscesses. We performed a prospective, randomized controlled trial in two urban emergency departments comparing a rapid molecular test with standard of care culture-based testing. Follow-up telephone calls were made at between 2 and 7 days, 1 month, and 3 months after discharge. Patients at least 18 years old presenting with a chief complaint of abscess, cellulitis, or insect bite and receiving incision and drainage were eligible. Seven hundred seventy-eight people were assessed for eligibility and 252 met eligibility criteria.
Interventions
DEVICEXpert MRSA/SA SSTI
Use of Xpert MRSA/SA SSTI assay
DIAGNOSTIC_TESTStandard culture
Sponsors
Johns Hopkins University
George Washington University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adults 18 years or older with community onset abscess
Exclusion criteria
* previous treatment for same abscess in past 14 days * postoperative infection * inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Antibiotic Usage at the Time of the ED Visit | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Clinical Improvement Post-treatment at One Week | 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 |
| Clinical Outcome at One or Three Months | 3 months | Recurrence of abscess within a three month time period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Xpert MRSA/SA SSTI Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay | 126 |
| Standard Culture Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay | 126 |
| Total | 252 |
Baseline characteristics
| Characteristic | Standard Culture | Xpert MRSA/SA SSTI | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 126 Participants | 126 Participants | 252 Participants |
| Age, Continuous | 36.5 years STANDARD_DEVIATION 13.8 | 36 years STANDARD_DEVIATION 13.4 | 36 years STANDARD_DEVIATION 13.4 |
| Region of Enrollment United States | 126 participants | 126 participants | 252 participants |
| Sex: Female, Male Female | 73 Participants | 63 Participants | 136 Participants |
| Sex: Female, Male Male | 53 Participants | 63 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants With Antibiotic Usage at the Time of the ED Visit
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
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Xpert MRSA/SA SSTI | Number of Participants With Antibiotic Usage at the Time of the ED Visit | 97 Participants |
| Standard Culture | Number of Participants With Antibiotic Usage at the Time of the ED Visit | 96 Participants |
Secondary
Clinical Outcome at One or Three Months
Recurrence of abscess within a three month time period
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Xpert MRSA/SA SSTI | Clinical Outcome at One or Three Months | 26 Participants |
| Standard Culture | Clinical Outcome at One or Three Months | 24 Participants |
Secondary
Participant Clinical Improvement Post-treatment at One Week
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
Time frame: 2 to 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Xpert MRSA/SA SSTI | Participant Clinical Improvement Post-treatment at One Week | 91 Participants |
| Standard Culture | Participant Clinical Improvement Post-treatment at One Week | 94 Participants |
p-value: >0.05Chi-squared