- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01523899
Antimicrobial Stewardship Through MRSA Diagnosis in Emergency Department (ED) Patients With Abscesses
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
District of Columbia
-
Washington, D.C., District of Columbia, Forenede Stater, 20037
- The George Washington University
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater
- Johns Hopkins University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Xpert MRSA/SA SSTI
use of the Xpert MRSA/SSTI diagnostic assay
|
Use of Xpert MRSA/SA SSTI assay
|
Aktiv komparator: Standard culture
performance of standard bacterial culture of abscess material
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Antibiotic Usage at the Time of the ED Visit
Tidsramme: 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
|
Baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Participant Clinical Improvement Post-treatment at One Week
Tidsramme: 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
|
2 to 7 days
|
Clinical Outcome at One or Three Months
Tidsramme: 3 months
|
Recurrence of abscess within a three month time period
|
3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Larissa S May, MD, The George Washington University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 030927
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Kutan Abscess
-
Radboud University Medical CenterAfsluttetAnterior Cutaneous Nerve Entrapment Syndrome (ACNES)Holland
Kliniske forsøg med Xpert MRSA/SA SSTI
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Massachusetts General HospitalAfsluttetMRSA koloniseringForenede Stater