Rapid molecular test (SeptiFast®) reduced time for adjustment of antibiotic treatment in comparison with conventional blood cultures in critically ill sepsis patients: a randomized controlled clinical trial (preliminary results)

Rodrigues, Cristhieni; Santos, Maria Cecília Loschiavo dos; Filho, H H Caiaffa; Charbel, Cecília Eugênia; Silva, Luciane de Carvalho Sarahyba da; Rossi, Flávia; Franco, Maria Renata Gomes; Siciliano, Rinaldo Focaccia; Strabelli, Tânia Mara Varejão

doi:10.1186/cc12926

Cited by 2 publications

(12 citation statements)

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“…The number of patients with therapy modification based on a positive diagnostic test was 4 out of 41 (9.8%) in the SeptiFast group and 5 out of 37 (13.5%) in the blood culture group. Rodrigues et al 100 reported a mean time to change in therapy of 580 minutes (9.7 hours) with SeptiFast, compared with 3007 minutes (50.1 hours) (p-value for the between-group difference = 0.004) for blood culture. The number of patients in whom an adjustment of treatment was performed was 6 out of 17 (35%) in the SeptiFast group and 7 out of 29 (24%) in the blood culture group.…”

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

“…community, emergency department, hospital, intensive/critical care, general/ specialist) was not reported for nine SeptiFast studies, 44,65,69,72,88,98,100,105,110 or for one multitest SeptiFast and SepsiTest study 118 (confidential information has been removed). The setting across the remaining studies varied (see Table 4).…”

Section: Study Design Characteristicsmentioning

confidence: 99%

“…Time to treatment Time to treatment was reported by three SeptiFast studies, one of which was the RCT by Tafelski et al 112 comparing SeptiFast with blood culture and MALDI-TOF MS, and two of which were the RCTs by Rodrigues et al 100 and Idelevich et al 110 comparing SeptiFast with blood culture. The time to treatment modification reported by all three RCTs was shorter in the SeptiFast group than in the blood culture group.…”

Section: Assessment Of Clinical Effectivenessmentioning

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%

“…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. 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).…”

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: Assessment Of Clinical Effectivenessmentioning

confidence: 99%