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<title lang=en>Empirical Micafungin Treatment and Survival Without Invasive Fungal Infection in Adults With ICU-Acquired Sepsis, Candida Colonization, and Multiple Organ Failure The EMPIRICUS Randomized Clinical Trial</title>
<creator>Klouche, Kada</creator>
<creator>Jaber, Samir</creator>
<creator>Trouillet, Jean-Louis</creator>
<creator>Bruneel, Fabrice</creator>
<creator>Argaud, Laurent</creator>
<creator>Cousson, Joel</creator>
<creator>Meziani, Ferhat</creator>
<creator>Gruson, Didier</creator>
<creator>Paris, Adeline</creator>
<creator>Darmon, Michael</creator>
<creator>Garrouste-Orgeas, Maïté</creator>
<creator>Navellou, Jean-Christophe</creator>
<creator>Foucrier, Arnaud</creator>
<creator>Allaouchiche, Bernard</creator>
<creator>Das, Vincent</creator>
<creator>Gangneux, Jean-Pierre</creator>
<creator>Ruckly, Stephane</creator>
<creator>Maubon, Danièle</creator>
<creator>Jullien, Vincent</creator>
<creator>Wolff, Michel</creator>
<creator>Timsit, Jean-François</creator>
<creator>Azoulay, Élie</creator>
<creator>Schwebel, Carole</creator>
<creator>Charles, Pierre Emmanuel</creator>
<creator>Cornet, Muriel</creator>
<creator>Souweine, Bertrand</creator>
<contributor>Département d'anesthésie-réanimation[Montpellier] ; Université Montpellier 1 (UM1) - Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier) - Hôpital Gui de Chauliac</contributor>
<contributor>Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp) ; Institut National de la Santé et de la Recherche Médicale (INSERM) - Université de Montpellier (UM) - Centre National de la Recherche Scientifique (CNRS)</contributor>
<contributor>Service de réanimation médicale , hôpital Pitié salpêtrière</contributor>
<contributor>Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition (ICAN) ; CHU Pitié-Salpêtrière [APHP] - Institut National de la Santé et de la Recherche Médicale (INSERM) - Assistance publique - Hôpitaux de Paris (AP-HP) - Université Pierre et Marie Curie - Paris 6 (UPMC)</contributor>
<contributor>réanimation chirurgicale, CH Versailles ; Ministère de la santé</contributor>
<contributor>Hôpital Edouard Herriot ; Hospices Civils de Lyon - Hôpital Edouard Herriot</contributor>
<contributor>Service de réanimation médicale ; CHU Reims</contributor>
<contributor>Laboratoire HIFIH ; Université d'Angers (UA)</contributor>
<contributor>Laboratoire de Biophotonique et Pharmacologie - UMR 7213 (LBP) ; Centre National de la Recherche Scientifique (CNRS)</contributor>
<contributor>Département d'Endocrinologie et Nutrition (LOUVAIN - Endocrino) ; Université Catholique de Louvain (UCL)</contributor>
<contributor>CIC - Grenoble ; Université Joseph Fourier - Grenoble 1 (UJF) - Institut National de la Santé et de la Recherche Médicale (INSERM)</contributor>
<contributor>CSE ; Centre européen de sociologie et de science politique (CESSP) ; Université Panthéon-Sorbonne (UP1) - École des hautes études en sciences sociales (EHESS) - Centre National de la Recherche Scientifique (CNRS) - Université Panthéon-Sorbonne (UP1) - École des hautes études en sciences sociales (EHESS) - Centre National de la Recherche Scientifique (CNRS)</contributor>
<contributor>Epidémiologie pronostique des cancers et affections graves ; Université Joseph Fourier - Grenoble 1 (UJF) - Institut National de la Santé et de la Recherche Médicale (INSERM)</contributor>
<contributor>Service de réanimation médicale ; Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon) - Hôpital Jean Minjoz</contributor>
<contributor>Reanimation Médicale et Infectieuse [Bichat] ; Assistance publique - Hôpitaux de Paris (AP-HP) - Hôpital Bichat-Claude Bernard</contributor>
<contributor>Service de Réanimation ; Hospices Civils de Lyon - Hôpital E. Herriot</contributor>
<contributor>Service de réanimation médicale ; Assistance publique - Hôpitaux de Paris (AP-HP) - Groupe Hospitalier Saint-Louis-Lariboisière- Fernand-Widal - Université Paris Diderot - Paris 7 (UPD7)</contributor>
<contributor>Institut de recherche, santé, environnement et travail [Rennes] (Irset) ; Université d'Angers (UA) - Université des Antilles et de la Guyane (UAG) - Université de Rennes 1 (UR1) - École des Hautes Études en Santé Publique [EHESP] (EHESP) - Institut National de la Santé et de la Recherche Médicale (INSERM) - Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )</contributor>
<contributor>Service de Parasitologie-Mycologie [Rennes] ; Université de Rennes 1 (UR1) - Hôpital Pontchaillou - CHU Pontchaillou [Rennes]</contributor>
<contributor>Institut de Biologie et Pathologie ; CHU Grenoble</contributor>
<contributor>Epilepsies de l'Enfant et Plasticité Cérébrale (U1129) ; Commissariat à l'énergie atomique et aux énergies alternatives (CEA) - Université Paris Descartes - Paris 5 (UPD5) - Institut National de la Santé et de la Recherche Médicale (INSERM)</contributor>
<contributor>Naval Research Laboratory (NRL)</contributor>
<contributor>Unité de Soins Intensifs et de Maladies Infectieuses ; Assistance publique - Hôpitaux de Paris (AP-HP) - Hôpital Bichat - Claude Bernard [Paris]</contributor>
<contributor>Infection, Antimicrobiens, Modélisation, Evolution (IAME) ; Université Paris Diderot - Paris 7 (UPD7) - Université Paris 13 (UP13) - Université Sorbonne Paris Cité (USPC) - Institut National de la Santé et de la Recherche Médicale (INSERM)</contributor>
<contributor>Hopital Saint Louis Paris ; CHU</contributor>
<contributor>Service de Réanimation Médicale ; CHU Grenoble - Hôpital Albert Michallon</contributor>
<contributor>Service de Réanimation Médicale (CHU de Dijon) ; Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon)</contributor>
<contributor>TheREx ; Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications [Grenoble] (TIMC-IMAG) ; Université Joseph Fourier - Grenoble 1 (UJF) - IMAG - Université de Lyon - Centre National de la Recherche Scientifique (CNRS) - Université Joseph Fourier - Grenoble 1 (UJF) - IMAG - Université de Lyon - Centre National de la Recherche Scientifique (CNRS)</contributor>
<contributor>Laboratoire Microorganismes : Génome et Environnement (LMGE) ; Université Blaise Pascal - Clermont-Ferrand 2 (UBP) - Centre National de la Recherche Scientifique (CNRS) - Université d'Auvergne - Clermont-Ferrand I (UdA)</contributor>
<contributor>Astellas</contributor>
<contributor> University of Grenoble 1/Albert Michallon University Hospital</contributor>
<description>International audience</description>
<source>ISSN: 0098-7484</source>
<source>EISSN: 1538-3598</source>
<source>Journal of the American Medical Association</source>
<publisher>American Medical Association (AMA)</publisher>
<identifier>hal-01405822</identifier>
<identifier>https://hal-univ-rennes1.archives-ouvertes.fr/hal-01405822</identifier>
<source>https://hal-univ-rennes1.archives-ouvertes.fr/hal-01405822</source>
<source>Journal of the American Medical Association, American Medical Association (AMA), 2016, 316 (15), pp.1555--1564. 〈10.1001/jama.2016.14655〉</source>
<identifier>DOI : 10.1001/jama.2016.14655</identifier>
<relation>info:eu-repo/semantics/altIdentifier/doi/10.1001/jama.2016.14655</relation>
<identifier>PUBMED : 27706483</identifier>
<relation>info:eu-repo/semantics/altIdentifier/pmid/27706483</relation>
<language>en</language>
<subject lang=en>critically-ill patients</subject>
<subject lang=en> placebo-controlled trial</subject>
<subject lang=en> intensive-care-unit</subject>
<subject lang=en> systemic antifungal therapy</subject>
<subject lang=en> double-blind</subject>
<subject lang=en> surgical-patients</subject>
<subject lang=en> septic shock</subject>
<subject lang=en> high-risk</subject>
<subject lang=en> multicenter</subject>
<subject lang=en> management</subject>
<subject>[SDV.EE.SANT] Life Sciences [q-bio]/Ecology, environment/Health</subject>
<type>info:eu-repo/semantics/article</type>
<type>Journal articles</type>
<description lang=en>IMPORTANCE Although frequently used in treating intensive care unit (ICU) patients with sepsis, empirical antifungal therapy, initiated for suspected fungal infection, has not been shown to improve outcome. OBJECTIVE To determine whether empirical micafungin reduces invasive fungal infection (IFI)-free survival at day 28. DESIGN, SETTING, AND PARTICIPANTS Multicenter double-blind placebo-controlled study of 260 nonneutropenic, nontransplanted, critically ill patients with ICU-acquired sepsis, multiple Candida colonization, multiple organ failure, exposed to broad-spectrum antibacterial agents, and enrolled between July 2012 and February 2015 in 19 French ICUs. INTERVENTIONS Empirical treatment with micafungin (100mg, once daily, for 14 days) (n = 131) vs placebo (n = 129). MAIN OUTCOMES AND MEASURES The primary end pointwas survival without proven IFI 28 days after randomization. Key secondary end points included new proven fungal infections, survival at day 28 and day 90, organ failure, serum (1-3)-beta-D-glucan level evolution, and incidence of ventilator-associated bacterial pneumonia. RESULTS Among 260 patients (mean age 63 years; 91 [35%] women), 251 (128, micafungin group; 123, placebo group) were included in the modified intent-to-treat analysis. Median values were 8 for Sequential Organ Failure Assessment (SOFA) score, 3 for number of Candida-colonized sites, and 99 pg/mL for level of (1-3)-beta-D-glucan. On day 28, there were 82 (68%) patients in the micafungin group vs 79 (60.2%) in the placebo group who were alive and IFI free (hazard ratio [HR], 1.35 [95% CI, 0.87-2.08]). Results were similar among patients with a (1-3)-beta-D-glucan level of greater than 80 pg/mL (n = 175; HR, 1.41 [95% CI, 0.85-2.33]). Day-28 IFI-free survival in patients with a high SOFA score (> 8) was not significantly different when compared between the micafungin vs placebo groups (HR, 1.69 [95% CI, 0.96-2.94]). Use of empirical micafungin decreased the rate of new invasive fungal infection in 4 of 128 patients (3%) in the micafungin group vs placebo (15/123 patients [12%]) (P =.008). CONCLUSIONS AND RELEVANCE Among nonneutropenic critically ill patients with ICU-acquired sepsis, Candida species colonization at multiple sites, and multiple organ failure, empirical treatment with micafungin, compared with placebo, did not increase fungal infection-free survival at day 28.</description>
<date>2016</date>
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