학술논문
Performance and economic evaluation of the molecular detection of pathogens for patients with severe infections: the EVAMICA open-label, cluster-randomised, interventional crossover trial
Document Type
Original Paper
Author
Cambau, Emmanuelle; Durand-Zaleski, Isabelle; Bretagne, Stéphane; Brun-Buisson, Christian; Cordonnier, Catherine; Duval, Xavier; Herwegh, Stéphanie; Pottecher, Julien; Courcol, René; Bastuji-Garin, Sylvie; Lefort, Agnès; Mantz, Jean; Pease, Sébastien; Lavagna, Leïla; Nicolas-Chanoine, Marie Hélène; Leflon, Véronique; Marcon, Estelle; Ruimy, Raymond; Andremont, Antoine; Lebras, Jacques; Iung, Bernard; Regnier, Bernard; Yeni, Patrick; Montravers, Philippe; Mourvillier, Bruno; Ilic-Habensus, Emila; Talbi, Nadia El Alami; Lasocki, Sigismond; Bouscary, Didier; Mira, Jean-Paul; Grimaldi, David; Marin, Nathalie; Doloy, Alexandra; Poyart, Claire; Scherrer, Emmanuel; Chambon-Pautas, Cecile; Cook, Fabrice; Mekontso-Dessap, Armand; Schortgen, Frédérique; Chedevergne, Karine; Vernant, Jean-Paul; Gauvin-Bodin, Liliane; Trouillet, Jean-Louis; Chastre, Jean; Bricaire, François; Brossier, Florence; Jarlier, Vincent; Dheder, Nathalie; Nieszkowska, Ania; Datry, Annick; Fekkar, Arnaud; Buffet, Pierre; Mazier, Rommy; Brun, Sophie; Meyssonnier, Vanina; Isnard, Françoise; Baudel, Jean-Luc; Meynard, Jean-Luc; Petit, Jean-Claude; Lalande, Valérie; Roux, Patricia; Raffoux, Emmanuel; Ribaud, Patricia; Das, Vincent; Schlemmer, Benoit; Azoulay, Elie; Chimot, Loic; Molina, Jean-Michel; Ponscarme, Diane; Pavie, Juliette; Simon, François; Casin, Isabelle; Menotti, Jean; Gruson, Didier; Bessède, Emilie; Guilhon, Emmanuelle; Accoceberry, Isabelle; Millet, Pascal; Bébéar, Cécile; Berthoux, Christian; Tonnelier, Jean-Marie; Garre, Michel; Hery-Arnaud, Geneviève; Payan, Christopher; Nevez, Gilles; Timsit, Jean-Francois; Cahn, Jean-Yves; Brion, Jean-Paul; Le beau, Bernard; Courby, Stephane; Pelloux, Hervé; Maurin, Max; Epaulard, Olivier; Hamidfar, Rebecca; Berthon, Céline; Coiteux, Valérie; Terriou, Louis; Nseir, Saadalla; Auffray, Jean-Luc; Jouet, Jean-Pierre; Durocher, Alain; Faure, Karine; Clavel, Marc; Camus, Daniel; Dugard, Anthony; Tisseuil, Chantal; Duchiron, Cécile; Ajzenberg, Daniel; Bordessoule, Dominique; Garnier, Fabien; François, Bruno; Ploy, Marie-Cécile; Darde, Marie-Laure; Chaury, Marie-Pierre; Giraud, Stephane; Jaccard, Arnaud; Moreau, Stéphane; Réménieras, Liliane; Touati, Mohamed; Turlure, Pascal; Amiel, Jean-Bernard; Pichon, Nicolas; Postil, Déborah; Vignon, Philippe; Espinouse, Daniel; Jacques, Didier; De Monbrison, Frédérique; Grozel, Jean-Michel; Chomarat, Monique; Gueugniaud, Pierre-Yves; Sanogo, Rokiatou; Drancourt, Michel; Fournier, Pierre Edouard; Roux, Véronique; Delmer, Alain; Himberlin, Chantal; Kolb, Brigitte; Lé, Quoc Hung; Appriou, Morgane; Cousson, Joël; Nazeyrollas, Pierre; Strady, Christophe; Dechamps, Christophe; Vernet, Véronique; Delmer, Alain; Toubas, Dominique; Guyotat, Denis; Auboyer, Christian; Zeni, Fabrice; Alamartine, Eric; Cathebras, Pascal; Lucht, Frédéric; Viallon, Alain; Melis, Adrien; Ros, Alain; Carricajo, Anne; Devanlay, Camille; Labruyere, Carine; Vautrin, Catherine; Cazorla, Céline; Tavernier, Emmanuelle; Grattard, Florence; Aubert, Gérald; Morel, Jerome; Cornillon, Jérome; Abba, Karima; Flori, Pierre; Sung, Roger Tran Manh; Pozzetto, Bruno; Schneider, Francis; Hansmann, Yves; Herbrecht, Raoul; Jaulhac, Benoit; Piémont, Yves; Lestcher, Valérie; Colombat, Philippe; Senecal, Delphine; Garot, Denis; Perrottin, Dominique; Besnier, Jean-Marc; Goudeau, Alain; Lanotte, Philippe; Chandenier, Jacques; Baloul, Samia; Corbel, Céline; Dabbech, Moufida; Gaba, Mabel; Jozefowicz, Elsa; Lafaye, Magali; Maugard, Fabien; Rabeuf, Remi; Rabetrano, Hasina; Veerabudun, Kalaivani; Viallette, Cédric; Stahl, Jean-Paul; Delhaes, Laurence; The EVAMICA study team
Source
Intensive Care Medicine. :1-13
Subject
Language
English
ISSN
0342-4642
1432-1238
1432-1238
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.