Molecular Early Sepsis Identification Study

NCT05833412 | Unknown FDA Device

• 1 other identifier: 182/2022
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Single-center, retrospective observational study to evaluate the implementation of early molecular diagnosis of sepsis using SeptiCyte and BCID2 in 120 critically ill patients with suspected sepsis without clear focus and requiring antimicrobial treatment. The main objective is to evaluate the performance of these molecular techniques with respect to routine clinical practice and their impact on the optimization of antimicrobial treatment in this group of patients.

Conditions

Sepsis; Molecular Diagnosis

Keywords

sepsis; Molecular diagnosis; Filmarrays

Outcome Measures

Primary Outcomes (2)

• To determine the ability of filmarryas BCID 2® for the early identification of microorganisms in BC with a few hours of incubation and before they have become positive

  The number of microorganisms identified by BCID2 after 6-8 hours of incubation with respect to the number of microorganisms identified by blood culture (gold standard).

  Observational period from blood culture collection to 7 days of incubation (period of completion of blood culture incubation when negative results are reported as definitive).

• To determine the ability of SeptiCyte® for the molecular diagnosis of sepsis in critically ill patients with unclear infectious focus.

  The number of patients classified as having a high, intermediate or no possibility of sepsis with respect to the same classification made on the basis of clinical and laboratory criteria by 3 physicians with expertise in infections at the time of resolution of the suspected sepsis.

  Observational period from the time of suspected sepsis (defined as the time of blood culture) until resolution of the probable sepsis (usually 7-10 days). Only the first episode of suspected sepsis will be considered for each patient.

Secondary Outcomes (1)

• To determine the possible impact of the results on the management (optimization) of antimicrobial treatment.

  Observational period from the time of suspected sepsis (defined as the time of blood culture) until resolution of the probable sepsis (usually 7-10 days).

Study Arms (1)

Suspected sepsis

These patients will undergo molecular diagnosis by performing the Septicyte Rapid® test on whole blood (EDTA) which allows to know the risk of sepsis (low, intermediate, high) and after 6-8 hours of blood culture incubation, filmarrays blood culture identification (BCID2®) a molecular test approved for direct identification of BSI causing pathogens from blood culture will be performed.

Diagnostic Test: Septicyte Rapid ®; Diagnostic Test: FilmArray® blood culture identification (BCID2®)

Interventions

Septicyte Rapid ® DIAGNOSTIC_TEST

SeptiCyte RAPID is based on the measurement of two gene expression biomarkers in peripheral blood (PLAC8 and PLA2G7) using quantitative reverse transcription-polymerase chain reaction (RT-qPCR). Based on the results obtained in 1 hour from whole blood (100 mcl), the device issues a report with a sepsis probability scale according to 4 bands (1 low probability, 2-3 intermediate probability and 4 high probability).

Suspected sepsis

FilmArray® blood culture identification (BCID2®) DIAGNOSTIC_TEST

After 6 to 8 hours of blood culture incubation, BCID2 will be performed on each of the 4 bottles. The BCID2 assay is an approved molecular test for the direct identification of pathogens causing bloodstream infections from blood cultures. The BCID2 Panel analyzes 43 targets associated with bloodstream infections, including Gram-negative bacteria, Gram-positive bacteria, yeasts and 10 antimicrobial resistance genes, all with a single test and with results available in approximately one hour from the blood culture. In addition, the BCID2® Panel menu includes seven additional resistance genes, including carbapenemases, colistin resistance genes and a MREJ assay that enables more specific MRSA identification.

Suspected sepsis

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critically ill patient who presents with highly suspected sepsis and requires antimicrobial treatment in the next 2-3 hours without evidence of a clear focus responsible for sepsis after an extensive assessment of the patient's condition.

You may qualify if:

• \- Age (\>15 years old)
• \- At least 2 SIRS criteria
• \- RCP (\> 10 mg/dL) or PCT (\> 0.5 ng/mL in community or \> 1.0ng/mL in nosocomial infection) elevated
• Without a clear focus that justifies sepsis 4.- High suspicion of infection that requires starting antimicrobial treatment.

You may not qualify if:

• \- Failure to obtain the samples within 12 hours after the infection is suspected and antibiotic administration
• \- Previous administration of antimicrobials in the last 24 hours
• \- Documented or evident sepsis focus on ICU admission

Sponsors & Collaborators

• Alejandro Rodriguez Oviedo , MD: lead
• BioMérieux: collaborator
• Biocartis NV: collaborator

Study Sites (1)

Alejandro Rodriguez

Tarragona, 43007, Spain

RECRUITING

Related Publications (17)

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 BACKGROUND

• Rodriguez A. Sepsis-3: More specific is better? Med Clin (Barc). 2019 Jan 4;152(1):17-18. doi: 10.1016/j.medcli.2018.07.006. Epub 2018 Sep 15. No abstract available. English, Spanish.

  PMID: 30227997 BACKGROUND

• Rodriguez A, Martin-Loeches I, Yebenes JC. New definition of sepsis and septic shock: What does it give us? Med Intensiva. 2017 Jan-Feb;41(1):38-40. doi: 10.1016/j.medin.2016.03.008. Epub 2016 May 30. No abstract available. English, Spanish.

  PMID: 27255771 BACKGROUND

• Yebenes JC, Ruiz-Rodriguez JC, Ferrer R, Cleries M, Bosch A, Lorencio C, Rodriguez A, Nuvials X, Martin-Loeches I, Artigas A; SOCMIC (Catalonian Critical Care Society) Sepsis Working Group. Epidemiology of sepsis in Catalonia: analysis of incidence and outcomes in a European setting. Ann Intensive Care. 2017 Dec;7(1):19. doi: 10.1186/s13613-017-0241-1. Epub 2017 Feb 20.

  PMID: 28220453 BACKGROUND

• Maharaj R, McGuire A, Street A. Association of Annual Intensive Care Unit Sepsis Caseload With Hospital Mortality From Sepsis in the United Kingdom, 2010-2016. JAMA Netw Open. 2021 Jun 1;4(6):e2115305. doi: 10.1001/jamanetworkopen.2021.15305.

  PMID: 34185067 BACKGROUND

• Kahn JM, Davis BS, Yabes JG, Chang CH, Chong DH, Hershey TB, Martsolf GR, Angus DC. Association Between State-Mandated Protocolized Sepsis Care and In-hospital Mortality Among Adults With Sepsis. JAMA. 2019 Jul 16;322(3):240-250. doi: 10.1001/jama.2019.9021.

  PMID: 31310298 BACKGROUND

• Li AT, Moussa A, Gus E, Paul E, Yii E, Romero L, Lin ZC, Padiglione A, Lo CH, Cleland H, Cheng AC. Biomarkers for the Early Diagnosis of Sepsis in Burns: Systematic Review and Meta-analysis. Ann Surg. 2022 Apr 1;275(4):654-662. doi: 10.1097/SLA.0000000000005198.

  PMID: 35261389 BACKGROUND

• Iankova I, Thompson-Leduc P, Kirson NY, Rice B, Hey J, Krause A, Schonfeld SA, DeBrase CR, Bozzette S, Schuetz P. Efficacy and Safety of Procalcitonin Guidance in Patients With Suspected or Confirmed Sepsis: A Systematic Review and Meta-Analysis. Crit Care Med. 2018 May;46(5):691-698. doi: 10.1097/CCM.0000000000002928.

  PMID: 29271844 BACKGROUND

• Metlay JP, Waterer GW, Long AC, Anzueto A, Brozek J, Crothers K, Cooley LA, Dean NC, Fine MJ, Flanders SA, Griffin MR, Metersky ML, Musher DM, Restrepo MI, Whitney CG. Diagnosis and Treatment of Adults with Community-acquired Pneumonia. An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45-e67. doi: 10.1164/rccm.201908-1581ST.

  PMID: 31573350 BACKGROUND

• Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratala J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL. Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):e61-e111. doi: 10.1093/cid/ciw353. Epub 2016 Jul 14.

  PMID: 27418577 BACKGROUND

• Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.

  PMID: 34599691 BACKGROUND

• Klein Klouwenberg PM, Cremer OL, van Vught LA, Ong DS, Frencken JF, Schultz MJ, Bonten MJ, van der Poll T. Likelihood of infection in patients with presumed sepsis at the time of intensive care unit admission: a cohort study. Crit Care. 2015 Sep 7;19(1):319. doi: 10.1186/s13054-015-1035-1.

  PMID: 26346055 BACKGROUND

• van Vught LA, Wiewel MA, Hoogendijk AJ, Frencken JF, Scicluna BP, Klein Klouwenberg PMC, Zwinderman AH, Lutter R, Horn J, Schultz MJ, Bonten MMJ, Cremer OL, van der Poll T. The Host Response in Patients with Sepsis Developing Intensive Care Unit-acquired Secondary Infections. Am J Respir Crit Care Med. 2017 Aug 15;196(4):458-470. doi: 10.1164/rccm.201606-1225OC.

  PMID: 28107024 BACKGROUND

• McHugh L, Seldon TA, Brandon RA, Kirk JT, Rapisarda A, Sutherland AJ, Presneill JJ, Venter DJ, Lipman J, Thomas MR, Klein Klouwenberg PM, van Vught L, Scicluna B, Bonten M, Cremer OL, Schultz MJ, van der Poll T, Yager TD, Brandon RB. A Molecular Host Response Assay to Discriminate Between Sepsis and Infection-Negative Systemic Inflammation in Critically Ill Patients: Discovery and Validation in Independent Cohorts. PLoS Med. 2015 Dec 8;12(12):e1001916. doi: 10.1371/journal.pmed.1001916. eCollection 2015 Dec.

  PMID: 26645559 BACKGROUND

• Verboom DM, Koster-Brouwer ME, Varkila MRJ, Bonten MJM, Cremer OL. Profile of the SeptiCyte LAB gene expression assay to diagnose infection in critically ill patients. Expert Rev Mol Diagn. 2019 Feb;19(2):95-108. doi: 10.1080/14737159.2019.1567333. Epub 2019 Feb 5.

  PMID: 30623693 RESULT

• Berinson B, Both A, Berneking L, Christner M, Lutgehetmann M, Aepfelbacher M, Rohde H. Usefulness of BioFire FilmArray BCID2 for Blood Culture Processing in Clinical Practice. J Clin Microbiol. 2021 Jul 19;59(8):e0054321. doi: 10.1128/JCM.00543-21. Epub 2021 Jul 19.

  PMID: 33980648 RESULT

• Massa-Buck B, Mendoza S, Keiser J, Mohamed MA. Use of Rapid Molecular Polymerase Chain Reaction in Early Detection of Bacteremia in Neonates Prior to Blood Culture Positivity: A Pilot Study. Am J Perinatol. 2024 Apr;41(5):569-574. doi: 10.1055/s-0042-1742743. Epub 2022 Feb 11.

  PMID: 35148542 RESULT

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ALEJANDRO RODRIGUEZ, MD,PhD,MSc

  Hospital Universitari de Tarragona Joan XXIII

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro Rodriguez, MD,PhD,MSc

CONTACT

+34626179726; ahr1161@yahoo.es

Sandra Trelfer, BSc,PhD

CONTACT

+34628796824; sitrefler@yahoo.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,PhD,MSc

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 27, 2023
• Study Start: April 12, 2023
• Primary Completion: April 17, 2023
• Study Completion: April 30, 2024
• Last Updated: May 3, 2023

Record last verified: 2023-05

Locations

ES (1)