Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xpert MRSA/SA SSTI | Experimental | use of the Xpert MRSA/SSTI diagnostic assay |
|
| Standard culture | Active Comparator | performance of standard bacterial culture of abscess material |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xpert MRSA/SA SSTI | Device | Use of Xpert MRSA/SA SSTI assay |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 to 7 days |
| Clinical Outcome at One or Three Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Larissa S May, MD | The George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The George Washington University | Washington D.C. | District of Columbia | 20037 | United States | ||
| Johns Hopkins University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26306996 | Derived | May LS, Rothman RE, Miller LG, Brooks G, Zocchi M, Zatorski C, Dugas AF, Ware CE, Jordan JA. A Randomized Clinical Trial Comparing Use of Rapid Molecular Testing for Staphylococcus aureus for Patients With Cutaneous Abscesses in the Emergency Department With Standard of Care. Infect Control Hosp Epidemiol. 2015 Dec;36(12):1423-30. doi: 10.1017/ice.2015.202. Epub 2015 Aug 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Xpert MRSA/SA SSTI | Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay |
| FG001 | Standard Culture | Standard bacterial culture and susceptibility testing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Xpert MRSA/SA SSTI | Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay |
| BG001 | Standard Culture | Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | Baseline |
|
Not provided
Adverse events were not expected with this diagnostic study and were not monitored for this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Xpert MRSA/SA SSTI | Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larissa May, MD | University of California-Davis | 9167345000 | lsmay@ucdavis.edu |
Not provided
| ID | Term |
|---|---|
| D005667 | Furunculosis |
| ID | Term |
|---|---|
| D013207 | Staphylococcal Skin Infections |
| D013203 | Staphylococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard culture |
| Diagnostic Test |
|
Recurrence of abscess within a three month time period |
| 3 months |
| Baltimore |
| Maryland |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| 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 | Posted | Count of Participants | Participants | 2 to 7 days |
|
|
|
|
| Secondary | Clinical Outcome at One or Three Months | Recurrence of abscess within a three month time period | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standard Culture | Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005393 | Fish Diseases |
| D000820 | Animal Diseases |