Clinical impact and cost-consequence analysis of ePlex® blood culture identification panels for the rapid diagnosis of bloodstream infections: a single-center randomized controlled trial.


Journal

European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology
ISSN: 1435-4373
Titre abrégé: Eur J Clin Microbiol Infect Dis
Pays: Germany
ID NLM: 8804297

Informations de publication

Date de publication:
27 Mar 2024
Historique:
received: 13 02 2024
accepted: 21 03 2024
medline: 27 3 2024
pubmed: 27 3 2024
entrez: 27 3 2024
Statut: aheadofprint

Résumé

To assess clinical impact and perform cost-consequence analysis of the broadest multiplex PCR panels available for the rapid diagnosis of bloodstream infections (BSI). Single-center, randomized controlled trial conducted from June 2019 to February 2021 at a French University hospital with an institutional antimicrobial stewardship program. Primary endpoint was the percentage of patients with optimized antimicrobial treatment 12 h after transmission of positivity and Gram stain results from the first positive BC. This percentage was significantly higher in the multiplex PCR (mPCR) group (90/105 = 85.7% %, CI95% [77.5 ; 91.8] vs. 68/107 = 63.6%, CI95% [53.7 ; 72.6]; p < 10

Identifiants

pubmed: 38536524
doi: 10.1007/s10096-024-04820-z
pii: 10.1007/s10096-024-04820-z
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024. The Author(s).

Références

Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR et al (2020) Global, regional, and national sepsis incidence and mortality, 1990–2017: analysis for the global burden of Disease Study. Lancet 395:200–211. https://doi.org/10.1016/S0140-6736(19)32989-7
doi: 10.1016/S0140-6736(19)32989-7 pubmed: 31954465 pmcid: 6970225
Murray CJ, Ikuta KS, Sharara F, Swetschinski L, Aguilar GR, Gray A et al Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet 2022 12;399:629–655. https://doi.org/10.1016/S0140-6736(21)02724-0
Seymour CW, Gesten F, Prescott HC, Friedrich ME, Iwashyna TJ, Phillips GS et al Time to treatment and mortality during mandated Emergency Care for Sepsis. N Engl J Med 2017 8;376:2235–2244. https://doi.org/10.1056/NEJMoa1703058
Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C et al (2021) Surviving sepsis campaign: International guidelines for management of Sepsis and Septic Shock 2021. Crit Care Med 49:e1063–e1143. https://doi.org/10.1097/CCM.0000000000005337
doi: 10.1097/CCM.0000000000005337 pubmed: 34605781
Van Heuverswyn J, Valik JK, van der Desirée S, Hedberg P, Giske C, Nauclér P association between time to appropriate antimicrobial treatment and 30-day mortality in patients with bloodstream infections: a retrospective cohort study. Clinical infectious diseases 2022 6;ciac727. https://doi.org/10.1093/cid/ciac727
Robineau O, Robert J, Rabaud C, Bedos J-P, Varon E, Péan Y et al Management and outcome of bloodstream infections: a prospective survey in 121 French hospitals (SPA-BACT survey). IDR 2018;Volume 11:1359–68. https://doi.org/10.2147/IDR.S165877
Lamy B, Sundqvist M, Idelevich EA, ESCMID Study Group for Bloodstream Infections (2020) Endocarditis and Sepsis (ESGBIES). Bloodstream infections - standard and progress in pathogen diagnostics. Clin Microbiol Infect 26:142–150. https://doi.org/10.1016/j.cmi.2019.11.017
doi: 10.1016/j.cmi.2019.11.017 pubmed: 31760113
Banerjee R, Teng CB, Cunningham SA, Ihde SM, Steckelberg JM, Moriarty JP et al (2015) Randomized Trial of Rapid Multiplex polymerase chain reaction–based blood culture identification and susceptibility testing. Clin Infect Dis 161:1071–1080. https://doi.org/10.1093/cid/civ447
doi: 10.1093/cid/civ447
Osthoff M, Gürtler N, Bassetti S, Balestra G, Marsch S, Pargger H et al (2017) Impact of MALDI-TOF-MS-based identification directly from positive blood cultures on patient management: a controlled clinical trial. Clin Microbiol Infect 23:78–85. https://doi.org/10.1016/j.cmi.2016.08.009
doi: 10.1016/j.cmi.2016.08.009 pubmed: 27569710
Timbrook TT, Morton JB, McConeghy KW, Caffrey AR, Mylonakis E, LaPlante KL (2017) The Effect of Molecular Rapid Diagnostic Testing on Clinical outcomes in Bloodstream infections: a systematic review and Meta-analysis. Clin Infect Dis 164:15–23. https://doi.org/10.1093/cid/ciw649
doi: 10.1093/cid/ciw649
Jasuja JK, Zimmermann S, Burckhardt I (2020) Evaluation of EUCAST rapid antimicrobial susceptibility testing (RAST) for positive blood cultures in clinical practice using a total lab automation. Eur J Clin Microbiol Infect Dis 39:1305–1313. https://doi.org/10.1007/s10096-020-03846-3
doi: 10.1007/s10096-020-03846-3 pubmed: 32112163 pmcid: 7303068
Pliakos EE, Andreatos N, Shehadeh F, Ziakas PD, Mylonakis E The cost-effectiveness of Rapid Diagnostic Testing for the diagnosis of Bloodstream infections with or without Antimicrobial Stewardship. Clin Microbiol Reviews 2018 30;31:e00095–e00017, /cmr/31/3/e00095-17.atom. https://doi.org/10.1128/CMR.00095-17
Zacharioudakis IM, Zervou FN, Shehadeh F, Mylonakis E Cost-effectiveness of molecular diagnostic assays for the therapy of severe sepsis and septic shock in the emergency department. PLoS ONE 2019 24;14:e0217508. https://doi.org/10.1371/journal.pone.0217508
Idelevich EA, Seifert H, Sundqvist M, Scudeller L, Amit S, Balode A et al (2019) Microbiological diagnostics of bloodstream infections in Europe—an ESGBIES survey. Clin Microbiol Infect 25:1399–1407. https://doi.org/10.1016/j.cmi.2019.03.024
doi: 10.1016/j.cmi.2019.03.024 pubmed: 30980927
Bryant S, Almahmoud I, Pierre I, Bardet J, Touati S, Maubon D et al (2020) Evaluation of Microbiological Performance and the potential clinical impact of the ePlex® Blood Culture Identification panels for the Rapid Diagnosis of Bacteremia and Fungemia. Front Cell Infect Microbiol 26:10:594951. https://doi.org/10.3389/fcimb.2020.594951
doi: 10.3389/fcimb.2020.594951
Timsit J-F, Soubirou J-F, Voiriot G, Chemam S, Neuville M, Mourvillier B et al (2014) Treatment of bloodstream infections in ICUs. BMC Infect Dis 14:489. https://doi.org/10.1186/1471-2334-14-489
doi: 10.1186/1471-2334-14-489 pubmed: 25431091 pmcid: 4289315
Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, Sharma S et al Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock*. Crit Care Med 2006 1;34:1589–1596. https://doi.org/10.1097/01.CCM.0000217961.75225.E9
Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
Société fraçaise de microbiologie CASFM / EUCAST V2.0 Mai 2019 [Internet]. doi: https://www.sfm-microbiologie.org/wp-content/uploads/2019/05/CASFM2019_V2.0_MAI.pdf
Emonet S, Charles PG, Harbarth S, Stewardson AJ, Renzi G, Uckay I et al Rapid molecular determination of methicillin resistance in staphylococcal bacteraemia improves early targeted antibiotic prescribing: a randomized clinical trial. Clin Microbiol Infect 2016 1;22:946.e9-946.e15. https://doi.org/10.1016/j.cmi.2016.07.022 10.1016/j.cmi.2016.07.022
Banerjee R, Komarow L, Virk A, Rajapakse N, Schuetz AN, Dylla B et al Randomized Trial evaluating clinical impact of RAPid IDentification and susceptibility testing for Gram-negative bacteremia: RAPIDS-GN. Clin Infect Dis 2020 6;73:e39–46. https://doi.org/10.1093/cid/ciaa528
Ehren K, Meißner A, Jazmati N, Wille J, Jung N, Vehreschild JJ et al Clinical impact of Rapid species Identification from positive blood cultures with same-day phenotypic Antimicrobial susceptibility testing on the management and outcome of Bloodstream infections. Clin Infect Dis 2020 17;70:1285–1293. https://doi.org/10.1093/cid/ciz406
MacVane SH, Nolte FS Benefits of adding a Rapid PCR-Based blood culture identification panel to an established antimicrobial stewardship program. J Clin Microbiol 2016 1;54:2455–2463. https://doi.org/10.1128/JCM.00996-16
Venkatesh B, Schlapbach L, Mason D, Wilks K, Seaton R, Lister P et al Impact of 1-hour and 3-hour sepsis time bundles on patient outcomes and antimicrobial use: a before and after cohort study. The Lancet Regional Health – Western Pacific [Internet] 2022 1 [cited 2022 25];18. https://www.thelancet.com/journals/lanwpc/article/PIIS2666-6065( https://doi.org/10.1016/j.lanwpc.2021.100305
Anton-Vazquez V, Hine P, Krishna S, Chaplin M, Planche T Rapid versus standard antimicrobial susceptibility testing to guide treatment of bloodstream infection. Cochrane Database Syst Rev [Internet] 2021 4 [cited 2022 2];2021. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8561756/doi : https://doi.org/10.1002/14651858.CD013235.pub2
Huang T-D, Melnik E, Bogaerts P, Evrard S, Glupczynski Y (2018) Evaluation of the ePlex Blood Culture Identification panels for detection of pathogens in Bloodstream infections. J Clin Microbiol 28:57:e01597–e01518. /jcm/57/2/JCM.01597-18.atom
Oberhettinger P, Zieger J, Autenrieth I, Marschal M, Peter S (2020) Evaluation of two rapid molecular test systems to establish an algorithm for fast identification of bacterial pathogens from positive blood cultures. Eur J Clin Microbiol Infect Dis 4. https://doi.org/10.1007/s10096-020-03828-5
Carroll KC, Reid JL, Thornberg A, Whitfield NN, Trainor D, Lewis S et al Clinical performance of the Novel GenMark Dx ePlex® Blood Culture ID Gram-positive panel. J Clin Microbiol 2020 29;JCM.01730-19, jcm;JCM.01730-19v1. https://doi.org/10.1128/JCM.01730-19
Wolk DM, Young S, Whitfield NN, Reid JL, Thornberg A, Carroll KC et al A Multicenter Clinical Study to demonstrate the diagnostic accuracy of the GenMark Dx ePlex Blood Culture Identification Gram-negative panel. J Clin Microbiol [Internet] 2021 7 [cited 2022 15]. https://journals.asm.org/doi/abs/10.1128/JCM.02484-20
Tansarli GS, Chapin KC A closer look at the laboratory impact of utilizing eplex blood culture identification panels: a workflow analysis using rapid molecular detection for positive blood cultures. Microbiology Spectrum [Internet] 2022 7 [cited 2022 1]. 10.1128/spectrum.01796-22. https://doi.org/journals-asm-org.insb.bib.cnrs.fr/doi/10.1128/spectrum.01796-22 .
McCarty TP, White CM, Meeder J, Moates D, Pierce HM, Edwards WS et al Analytical performance and potential clinical utility of the GenMark Dx ePlex® blood culture identification gram-positive panel. Diagn Microbiol Infect Disease 2022 1;104:115762. https://doi.org/10.1016/j.diagmicrobio.2022.115762
Zhang SX, Carroll KC, Lewis S, Totten M, Mead P, Samuel L et al Multi-center evaluation of a PCR-based Digital Microfluidics and Electrochemical Detection System for the Rapid Identification of 15 fungal pathogens directly from positive blood cultures. J Clin Microbiol 2020 19;JCM.02096-19, jcm;JCM.02096-19v1. https://doi.org/10.1128/JCM.02096-19
Ransom EM, Alipour Z, Wallace MA, Burnham C-AD Evaluation of optimal blood culture incubation time to maximize clinically relevant results from a contemporary blood Culture Instrument and Media System. J Clin Microbiol 2021 18;59:e02459–e02420. https://doi.org/10.1128/JCM.02459-20
Maubon D, Dard C, Garnaud C, Cornet M (2018) Profile of GenMark’s ePlex® blood culture identification fungal pathogen panel. Expert Rev Mol Diagn 18:119–132. https://doi.org/10.1080/14737159.2018.1420476
doi: 10.1080/14737159.2018.1420476 pubmed: 29284316
Kim J-H, Kim I, Kang CK, Jun K-I, Yoo SH, Chun JY et al Enhanced antimicrobial stewardship based on rapid phenotypic antimicrobial susceptibility testing for bacteraemia in patients with haematological malignancies: a randomized controlled trial. Clin Microbiol Infect 2021 1;27:69–75. https://doi.org/10.1016/j.cmi.2020.03.038

Auteurs

Yvan Caspar (Y)

Laboratoire de Bactériologie-Hygiène Hospitalière, CHU Grenoble Alpes, Grenoble, France. YCaspar@chu-grenoble.fr.
Univ. Grenoble Alpes, CNRS, CHU Grenoble Alpes, CEA, IBS, Grenoble, 38000, France. YCaspar@chu-grenoble.fr.

A Deves (A)

Laboratoire de Bactériologie-Hygiène Hospitalière, CHU Grenoble Alpes, Grenoble, France.

C Richarme (C)

Laboratoire de Bactériologie-Hygiène Hospitalière, CHU Grenoble Alpes, Grenoble, France.

M Le Marechal (M)

Service des Maladies infectieuses et tropicales, CHU Grenoble Alpes, Grenoble, France.

L Ponderand (L)

Laboratoire de Bactériologie-Hygiène Hospitalière, CHU Grenoble Alpes, Grenoble, France.
Univ. Grenoble Alpes, CNRS, CHU Grenoble Alpes, CEA, IBS, Grenoble, 38000, France.

A-L Mounayar (AL)

Service des Maladies infectieuses et tropicales, CHU Grenoble Alpes, Grenoble, France.

S Lejeune (S)

Service des Maladies infectieuses et tropicales, CHU Grenoble Alpes, Grenoble, France.

J Arata-Bardet (J)

Service des Maladies infectieuses et tropicales, CHU Grenoble Alpes, Grenoble, France.

M Gallouche (M)

Univ. Grenoble Alpes, CNRS, UMR 5525, VetAgro Sup, Grenoble INP, CHU Grenoble Alpes, TIMC, Grenoble, 38000, France.
Service d'Hygiène Hospitalière, CHU Grenoble Alpes, Grenoble, France.

C Recule (C)

Laboratoire de Bactériologie-Hygiène Hospitalière, CHU Grenoble Alpes, Grenoble, France.

D Maubon (D)

Laboratoire de Parasitologie-Mycologie, CHU Grenoble Alpes, Grenoble, France.
University Grenoble Alpes, CNRS, CHU Grenoble Alpes, TIMC, Grenoble, 38000, France.

C Garnaud (C)

Laboratoire de Parasitologie-Mycologie, CHU Grenoble Alpes, Grenoble, France.
University Grenoble Alpes, CNRS, CHU Grenoble Alpes, TIMC, Grenoble, 38000, France.

M Cornet (M)

Laboratoire de Parasitologie-Mycologie, CHU Grenoble Alpes, Grenoble, France.
University Grenoble Alpes, CNRS, CHU Grenoble Alpes, TIMC, Grenoble, 38000, France.

M Veloso (M)

Cellule d'ingénierie des données, CHU Grenoble Alpes, Grenoble, France.

B Chabani (B)

Unité d'évaluation médico-économique, Pôle Santé Publique, CHU Grenoble Alpes, Grenoble, France.

M Maurin (M)

Laboratoire de Bactériologie-Hygiène Hospitalière, CHU Grenoble Alpes, Grenoble, France.
University Grenoble Alpes, CNRS, CHU Grenoble Alpes, TIMC, Grenoble, 38000, France.

S David-Tchouda (S)

Unité d'évaluation médico-économique, Pôle Santé Publique, CHU Grenoble Alpes, Grenoble, France.
CIC 1406 Grenoble, INSERM, Grenoble, 38000, France.
Univ. Grenoble Alpes, TIMC-Imag UMR 5525, Grenoble, 38000, France.

P Pavese (P)

Service des Maladies infectieuses et tropicales, CHU Grenoble Alpes, Grenoble, France.

Classifications MeSH