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Intensive Care Medicine
Published in: Intensive Care Medicine 11/2017

Open Access 01-11-2017 | Original

Performance and economic evaluation of the molecular detection of pathogens for patients with severe infections: the EVAMICA open-label, cluster-randomised, interventional crossover trial

Authors: Emmanuelle Cambau, Isabelle Durand-Zaleski, Stéphane Bretagne, Christian Brun-Buisson, Catherine Cordonnier, Xavier Duval, Stéphanie Herwegh, Julien Pottecher, René Courcol, Sylvie Bastuji-Garin, The EVAMICA study team

Published in: Intensive Care Medicine | Issue 11/2017

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Abstract

Purpose

Microbiological diagnosis (MD) of infections remains insufficient. The resulting empirical antimicrobial therapy leads to multidrug resistance and inappropriate treatments. We therefore evaluated the cost-effectiveness of direct molecular detection of pathogens in blood for patients with severe sepsis (SES), febrile neutropenia (FN) and suspected infective endocarditis (SIE).

Methods

Patients were enrolled in a multicentre, open-label, cluster-randomised crossover trial conducted during two consecutive periods, randomly assigned as control period (CP; standard diagnostic workup) or intervention period (IP; additional testing with LightCycler®SeptiFast). Multilevel models used to account for clustering were stratified by clinical setting (SES, FN, SIE).

Results

A total of 1416 patients (907 SES, 440 FN, 69 SIE) were evaluated for the primary endpoint (rate of blood MD). For SES patients, the MD rate was higher during IP than during CP [42.6% (198/465) vs. 28.1% (125/442), odds ratio (OR) 1.89, 95% confidence interval (CI) 1.43–2.50; P < 0.001], with an absolute increase of 14.5% (95% CI 8.4–20.7). A trend towards an association was observed for SIE [35.4% (17/48) vs. 9.5% (2/21); OR 6.22 (0.98–39.6)], but not for FN [32.1% (70/218) vs. 30.2% (67/222), P = 0.66]. Overall, turn-around time was shorter during IP than during CP (22.9 vs. 49.5 h, P < 0.001) and hospital costs were similar (median, mean ± SD: IP €14,826, €18,118 ± 17,775; CP €17,828, €18,653 ± 15,966). Bootstrap analysis of the incremental cost-effectiveness ratio showed weak dominance of intervention in SES patients.

Conclusion

Addition of molecular detection to standard care improves MD and thus efficiency of healthcare resource usage in patients with SES.
ClinicalTrials.gov registration number: NCT00709358.
Appendix
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Metadata
Title
Performance and economic evaluation of the molecular detection of pathogens for patients with severe infections: the EVAMICA open-label, cluster-randomised, interventional crossover trial
Authors
Emmanuelle Cambau
Isabelle Durand-Zaleski
Stéphane Bretagne
Christian Brun-Buisson
Catherine Cordonnier
Xavier Duval
Stéphanie Herwegh
Julien Pottecher
René Courcol
Sylvie Bastuji-Garin
The EVAMICA study team
Publication date
01-11-2017
Publisher
Springer Berlin Heidelberg
Published in
Intensive Care Medicine / Issue 11/2017
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-017-4766-4

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