Impact of Rapid Pathogen Identification From Blood Cultures (RABbIT)

Impact of Rapid Pathogen Identification From Blood Cultures (RABbIT - Rapid Blood Culture Intervention Trial)

Sponsoren

Hauptsponsor: Tan Tock Seng Hospital

Mitarbeiter: Mayo Clinic

Quelle Tan Tock Seng Hospital
Kurze Zusammenfassung

Septic shock carries high mortality, which may be exacerbated by inappropriate initial therapy. Inappropriate therapy may result from unanticipated antimicrobial resistance. Conversely, positive blood cultures may result from contamination, leading to unnecessary therapy and procedures and possibly prolonged hospitalization. Clinicians may also resort to broad spectrum antimicrobials and be hesitant to de-escalate while awaiting susceptibility results.

The investigators hypothesize that rapid identification of pathogens and antimicrobial resistance will ameliorate the above problems and improve time to optimal therapy, avoid unnecessary therapy and ultimately improve patient outcomes. While there are a number of in-vitro and uncontrolled clinical studies, there is a paucity of well-designed clinical trials objectively examining the real-world clinical and health-economic impact of such technology. To date only one randomised trial has been performed in the US (ClinicalTrials.gov NCT01898208), at a setting with low endemic rates of antimicrobial resistance. This is a companion study to NCT01898208. The investigators aim to study the clinical impact and cost-effectiveness of a strategy for rapid pathogen and resistance detection in a setting with a moderate to high levels of antimicrobial resistance.

detaillierte Beschreibung

Hypothesis:

1. Rapid pathogen identification from blood cultures, including early identification of resistance (via specific genetic markers or phenotypic tests), will allow timelier initiation of appropriate antibiotic therapy and improved patient outcomes

2. Rapid organism identification from blood cultures will allow timelier initiation of effective and optimal antibiotic therapy; minimizing the use of unnecessary antibiotics, including combination therapy

Devices to be studied for this proposed study:

1. BCID panel (Biofire Diagnostics Inc., bioMerieux) : The BCID panel is an FDA-approved nucleic acid amplification test (based on nested polymerase chain reaction) which detects Gram positive, Gram negative, the major Candida species and antimicrobial resistance markers (mecA for methicillin resistance, van A/B for vancomycin resistance, blaKPC for Klebsiella pneumoniae carbapenemase (KPC)) directly from positive blood cultures in < 1 - 1.5 hours

2. Rosco Diagnostica extended-spectrum beta-lactamase (ESBL) and carbapenemase screen kit (Rosco Diagnostica): These kits are CE-marked (Approved in the European Union) rapid chromogenic tests for ESBL/ carbapenemase detection from both blood cultures and cultured bacterial colonies.

Gesamtstatus Active, not recruiting
Anfangsdatum March 20, 2017
Fertigstellungstermin July 2, 2020
Primäres Abschlussdatum July 2, 2019
Phase N/A
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Time from positive blood culture result to effective/optimal antibiotics Approximately 14 days after positive blood culture
Sekundäres Ergebnis
Messen Zeitfenster
Clinical outcome (Infection related mortality) 1 year
Clinical outcome (All-cause related mortality) 1 year
Clinical outcome (Quality of life) 1 year
Time from positive blood culture result to bacterial identification Approximately 3 days
Duration of hospitalization (days) Participants were followed for the duration of hospital stay, approximately 28 days
Duration of bacteremia/fungemia (days) Patient-dependent variable, estimated up to 7 days
Time to isolation precautions Estimated up to 5 days
Antibiotic-associated adverse events Approximately 14 days after positive blood culture
Antimicrobial utilization (hours/days of therapy) Approximately 4 days after enrollment
Mean Total Hospitalization Costs Per Subject Approximately 7 days after positive blood culture for up to an estimated 24 weeks
Mean Laboratory Costs Per Subject Approximately 7 days after positive blood culture for up to an estimated 24 week
Mean Antimicrobials Costs Per Subject Approximately 7 days after positive blood culture and for duration of entire hospitalization
Cost-effectiveness analysis Up to 1 year after enrolment and using a 'modeled horizon' based on sepsis-adjusted life expectancies
Time on effective/optimal antibiotics within first 96 hours of positive blood culture First 96 hours after blood culture turns positive
Einschreibung 832
Bedingung
Intervention

Interventionsart: Device

Interventionsname: Filmarray Blood Culture ID (BCID) panel

Beschreibung: The BCID panel is an FDA-approved nucleic acid amplification test (based on nested polymerase chain reaction) which detects Gram positive, Gram negative, the major Candida species and antimicrobial resistance markers (mecA for methicillin resistance, van A/B for vancomycin resistance, blaKPC for KPC carbapenemase) directly from positive blood cultures in < 1 - 1.5 hours

Armgruppenetikett: Rapid diagnostic arm

Anderer Name: BCID

Interventionsart: Device

Interventionsname: Rosco Diagnostica ESBL/carbapenemase screen kit

Beschreibung: These kits are CE-marked (Approved in the European Union) rapid chromogenic tests for extended-spectrum beta-lactamase / carbapenemase detection from both blood cultures and cultured bacterial colonies.

Armgruppenetikett: Rapid diagnostic arm

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

1. Age > 21 years and above to 103 years

2. Blood culture flagged positive on automated instrument, with Gram positive, Gram negative bacteria or Yeast on Gram staining (including polymicrobial blood cultures)

3. Ability to provide informed consent or ability to obtain informed consent from legal guardian/representative (verbal and written)

Exclusion Criteria:

1. Patients whose blood cultures turn positive, but have no organism seen on Gram stain.

2. Patients who have been previously enrolled.

3. Patients who withdraw their consent (verbal or written).

4. Patients with any positive blood culture in the preceding 7 days.

Geschlecht: All

Mindestalter: 21 Years

Maximales Alter: 103 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Ort
Einrichtung: Tan Tock Seng Hospital
Standort Länder

Singapore

Überprüfungsdatum

September 2019

Verantwortliche Partei

Art: Principal Investigator

Ermittlerzugehörigkeit: Tan Tock Seng Hospital

Vollständiger Name des Ermittlers: Shawn Vasoo

Ermittlertitel: Consultant

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: Rapid diagnostic arm

Art: Experimental

Beschreibung: Standard Tan Tock Seng Hospital (TTSH) practices (bacterial culture and susceptibility testing) AND FilmArray Blood Culture ID (BCID) Panel test AND Rosco Diagnostica ESBL and carbapenemase screen will be performed. The Interventions to be administered are the rapid diagnostic tests: FilmArray Blood Culture ID (BCID) Panel test AND Rosco Diagnostica ESBL and carbapenemase screen. Subjects will be recruited 8am-3pm daily, weekdays only. Results of the BCID and Rosco test will be communicated to the managing physicians by phone in real-time.

Etikette: Standard of care (control)

Art: No Intervention

Beschreibung: Standard Tan Tock Seng Hospital (TTSH) practices (bacterial culture and susceptibility testing) will be used. FilmArray BCID and Rosco Diagnostica ESBL and carbapenemase screen will NOT be performed. Subjects will be recruited 8am-3pm daily, weekdays only.

Akronym RABbIT
Patientendaten No
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Diagnostic

Maskierung: Single (Participant)

Quelle: ClinicalTrials.gov