Randomized controlled clinical trial evaluating multiplex polymerase chain reaction for pathogen identification and therapy adaptation in critical care patients with pulmonary or abdominal sepsis

Tafelski, Sascha; Nachtigall, Irit; Adam, Thomas C.; Bereswill, Stefan; Faust, Jana; Tamarkin, Andrey; Trefzer, Timo B.; Deja, Maria; Idelevich, Evgeny A.; Wernecke, Klaus‐Dieter; Becker, Karsten; Spies, Claudia

doi:10.1177/0300060514561135

Cited by 22 publications

(43 citation statements)

References 27 publications

(47 reference statements)

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“…45,69,[71][72][73][74][75][76][77][78][80][81][82][83][85][86][87][90][91][92][93][94][96][97][98][99][101][102][103]107,[109][110][111][112]114 Of these, nine studies reported blood volumes that did not comply with CE approval: Lehmann et al, 76 Lodes et al 92 and von Lilienfeld-Toal et al 71 all reported using 1 ml in adults; Bloos et al, 74 Lamoth et al, 75 Paolucci et al 99 and Sitnik et al 107 all reported using 3 ml in adults; Berger et al…”

Section: Details Of Index and Reference Tests Blood Sampling Methodsmentioning

confidence: 99%

“…The setting across the remaining studies varied (see Table 4). Explicit inclusion and exclusion criteria for patients were reported for seven SeptiFast studies, 74,80,83,106,[110][111][112] (confidential information has been removed) and one IRIDICA study. 116 With the exception of the SeptiFast study by Warhurst et al, 111 which reported on health-care-associated bloodstream infections, and the SeptiFast study by Josefson et al, 85 which reported on community-acquired bloodstream infections, reporting of whether infection was community or hospital acquired was unclear in the remainder of the included studies.…”

Section: Study Design Characteristicsmentioning

confidence: 99%

“…Ten SeptiFast studies 45,46,64,70,93,94,102,105,106,112 and one IRIDICA study 116 reported on the proportion of the included patients who were immunocompromised. In addition, Paolucci et al 69 reported that one patient was affected by primary congenital immunodeficiency; however, it was unclear if other immunocompromised patients were included in this study.…”

Section: Patient Characteristics Of Included Studiesmentioning

confidence: 99%

“…The SeptiFast studies by Herne et al 97 and Lehmann et al 76 reported that all included patients had severe sepsis. Seven SeptiFast studies 46,77,80,83,100,106,112 and the one multitest SeptiFast and SepsiTest study 119 reported mixed samples of patients with sepsis, severe sepsis and septic shock in varying proportions. The SeptiFast RCT by Rodrigues et al 100 reported a mean APACHE II score of 17 for the SeptiFast group and 17 for the blood culture group, but was unclear whether or not this was at study entry or following testing.…”

Section: Patient Characteristics Of Included Studiesmentioning

confidence: 99%

“…The SeptiFast RCT by Rodrigues et al 100 reported a mean APACHE II score of 17 for the SeptiFast group and 17 for the blood culture group, but was unclear whether or not this was at study entry or following testing. The SeptiFast RCT by Tafelski et al 112 reported a median SAPS II on admission for the SeptiFast group of 40 (interquartile range 32-50) and the blood culture group of 47 (interquartile range 34-65). Schreiber and Nierhaus 119 also reported a median SAPS II score of 41 (interquartile range 33 to 49) for the entire cohort.…”

Section: Patient Characteristics Of Included Studiesmentioning

confidence: 99%

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Sepsis: the LightCycler SeptiFast Test MGRADE®, SepsiTest™ and IRIDICA BAC BSI assay for rapidly identifying bloodstream bacteria and fungi – a systematic review and economic evaluation

Stevenson

Pandor

James

et al. 2016

Health Technol Assess

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BackgroundSepsis can lead to multiple organ failure and death. Timely and appropriate treatment can reduce in-hospital mortality and morbidity.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of three tests [LightCycler SeptiFast Test MGRADE®(Roche Diagnostics, Risch-Rotkreuz, Switzerland); SepsiTestTM(Molzym Molecular Diagnostics, Bremen, Germany); and the IRIDICA BAC BSI assay (Abbott Diagnostics, Lake Forest, IL, USA)] for the rapid identification of bloodstream bacteria and fungi in patients with suspected sepsis compared with standard practice (blood culture with or without matrix-absorbed laser desorption/ionisation time-of-flight mass spectrometry).Data sourcesThirteen electronic databases (including MEDLINE, EMBASE and The Cochrane Library) were searched from January 2006 to May 2015 and supplemented by hand-searching relevant articles.Review methodsA systematic review and meta-analysis of effectiveness studies were conducted. A review of published economic analyses was undertaken and a de novo health economic model was constructed. A decision tree was used to estimate the costs and quality-adjusted life-years (QALYs) associated with each test; all other parameters were estimated from published sources. The model was populated with evidence from the systematic review or individual studies, if this was considered more appropriate (base case 1). In a secondary analysis, estimates (based on experience and opinion) from seven clinicians regarding the benefits of earlier test results were sought (base case 2). A NHS and Personal Social Services perspective was taken, and costs and benefits were discounted at 3.5% per annum. Scenario analyses were used to assess uncertainty.ResultsFor the review of diagnostic test accuracy, 62 studies of varying methodological quality were included. A meta-analysis of 54 studies comparing SeptiFast with blood culture found that SeptiFast had an estimated summary specificity of 0.86 [95% credible interval (CrI) 0.84 to 0.89] and sensitivity of 0.65 (95% CrI 0.60 to 0.71). Four studies comparing SepsiTest with blood culture found that SepsiTest had an estimated summary specificity of 0.86 (95% CrI 0.78 to 0.92) and sensitivity of 0.48 (95% CrI 0.21 to 0.74), and four studies comparing IRIDICA with blood culture found that IRIDICA had an estimated summary specificity of 0.84 (95% CrI 0.71 to 0.92) and sensitivity of 0.81 (95% CrI 0.69 to 0.90). Owing to the deficiencies in study quality for all interventions, diagnostic accuracy data should be treated with caution. No randomised clinical trial evidence was identified that indicated that any of the tests significantly improved key patient outcomes, such as mortality or duration in an intensive care unit or hospital. Base case 1 estimated that none of the three tests provided a benefit to patients compared with standard practice and thus all tests were dominated. In contrast, in base case 2 it was estimated that all cost per QALY-gained values were below £20,000; the IRIDICA BAC BSI assay had the highest estimated incremental net benefit, but results from base case 2 should be treated with caution as these are not evidence based.LimitationsRobust data to accurately assess the clinical effectiveness and cost-effectiveness of the interventions are currently unavailable.ConclusionsThe clinical effectiveness and cost-effectiveness of the interventions cannot be reliably determined with the current evidence base. Appropriate studies, which allow information from the tests to be implemented in clinical practice, are required.Study registrationThis study is registered as PROSPERO CRD42015016724.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Details Of Index and Reference Tests Blood Sampling Methodsmentioning

confidence: 99%

Section: Study Design Characteristicsmentioning

confidence: 99%

Section: Patient Characteristics Of Included Studiesmentioning

confidence: 99%

Section: Patient Characteristics Of Included Studiesmentioning

confidence: 99%

Section: Patient Characteristics Of Included Studiesmentioning

confidence: 99%

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Sepsis: the LightCycler SeptiFast Test MGRADE®, SepsiTest™ and IRIDICA BAC BSI assay for rapidly identifying bloodstream bacteria and fungi – a systematic review and economic evaluation

Stevenson

Pandor

James

et al. 2016

Health Technol Assess

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Bloodstream infections – Standard and progress in pathogen diagnostics

Lamy

Sundqvist

Idelevich

et al. 2020

Clinical Microbiology and Infection

128

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Background: Bloodstream infection (BSI) is a major public health burden worldwide, with high mortality. Patient outcome is critically influenced by delayed therapy, and fast and accurate pathogen diagnostics decisively improves the care of patients. During the past two decades major improvements have been made in the diagnostic performance of blood culture diagnostics through actions on pre-analysis and time to result. Aims: To review and discuss the literature for standard procedures and the progress in BSI pathogen diagnostics, and to propose a new mindset to reach an improved diagnostic workflow. Sources: Scientific articles and reviews available through NCBI/Pubmed. Content: Blood culture performance relies largely on the quality of its pre-analytical phase that is improved with educational actions monitored by using key performance indicators, and external quality assessment. Advanced blood culture systems now provide tools for an automated estimation of bottle filling. These proved efficient to facilitate effective training for improving blood collection. On analytic aspects, rapid methods for pathogen identification, among which matrix-assisted laser desorption/ ionization time of flight mass spectrometry dominates, and rapid antimicrobial susceptibility testing are reviewed. These technical developments call for improvements in all other steps, especially in pre-and post-analytic logistics to give the full reciprocation of these techniques on patient management. This aspect is summarized by the term 'microbiologistics', which covers all possible improvements in the logistic chain from sampling to report. Implications: Progress in BSI pathogen diagnostics is based on a bundle approach that includes optimization of the pre-analytical parameters, rapid start of incubation, the use of rapid methods, reorganization (e.g. 24/7, transportation service) and a close involvement of antimicrobial stewardship teams. These developments lead to define a new standard for bloodstream infection diagnostics.

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Multiplex PCR assay underreports true bloodstream infections with coagulase-negative staphylococci in hematological patients with febrile neutropenia

Reers

Idelevich

Pätkau

et al. 2016

Diagnostic Microbiology and Infectious Disease

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Randomized controlled clinical trial evaluating multiplex polymerase chain reaction for pathogen identification and therapy adaptation in critical care patients with pulmonary or abdominal sepsis

Abstract: The LightCycler® SeptiFast PCR test demonstrated a significant reduction in the time required for initial pathogen identification, compared with standard BC.

Cited by 22 publications

References 27 publications

Sepsis: the LightCycler SeptiFast Test MGRADE®, SepsiTest™ and IRIDICA BAC BSI assay for rapidly identifying bloodstream bacteria and fungi – a systematic review and economic evaluation

Sepsis: the LightCycler SeptiFast Test MGRADE®, SepsiTest™ and IRIDICA BAC BSI assay for rapidly identifying bloodstream bacteria and fungi – a systematic review and economic evaluation

Bloodstream infections – Standard and progress in pathogen diagnostics

Multiplex PCR assay underreports true bloodstream infections with coagulase-negative staphylococci in hematological patients with febrile neutropenia

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