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EMPIRICUS micafungin versus placebo during nosocomial sepsis in Candida multi-colonized ICU patients with multiple organ failures: study protocol for a randomized controlled trial.
Auteur(s) : Timsit, Jean-François Azoulay, Elie Cornet, Muriel Gangneux, Jean-Pierre Jullien, Vincent Vésin, Aurélien Schir, Edith Wolff, Michel
Auteurs secondaires : Service de Soins Intensifs [Michallon] ; Université Joseph Fourier - Grenoble 1 (UJF) - CHU Grenoble - Hôpital Michallon Outcomerea Organization ; Outcomerea Unité de Soins Intensifs et de Maladies Infectieuses ; Assistance publique - Hôpitaux de Paris (AP-HP) - Hôpital Bichat - Claude Bernard [Paris] Unité de Soins Intensifs [Saint-Louis] ; Assistance publique - Hôpitaux de Paris (AP-HP) - Groupe Hospitalier Saint-Louis-Lariboisière- Fernand-Widal 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) 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 ) Epilepsies de l'Enfant et Plasticité Cérébrale (U1129) ; Institut National de la Santé et de la Recherche Médicale (INSERM) - Commissariat à l'énergie atomique et aux énergies alternatives (CEA) - Université Paris Descartes - Paris 5 (UPD5) Epidémiologie pronostique des cancers et affections graves ; Université Joseph Fourier - Grenoble 1 (UJF) - Institut National de la Santé et de la Recherche Médicale (INSERM)

Éditeur(s) : HAL CCSD BioMed Central
Résumé : International audience
BACKGROUND: The potential interest of antifungal treatment of non-immunocompromized patients with sepsis, extra-digestive Candida colonization and multiple organ failure is unknown. It represents three-quarters of antifungals prescribed in Intensive Care Units. It may allow early treatment of invasive fungal infection in the incubation phase but expose patients to unnecessary antifungal treatments with subsequent cost and fungal selection pressure. As early diagnostic tests for invasive candidiasis are still considered to be insufficient, the potential interest in this strategy needs to be demonstrated. METHODS: This prospective multicenter, double blind, randomized-controlled trial is conducted in 23 French Intensive Care Units. All adult patients, mechanically ventilated for more than four days with sepsis of unknown origin and with at least one extradigestive fungal colonization site and multiple organ failure are eligible for randomization. Patients with proven invasive candidiasis are not included. After a complete mycological screening, patients are allocated to receive micafungin 100 mg intravenously once a day or placebo for 14 days. We plan to enroll 260 patients. The main objective is to demonstrate that micafungin increases survival of patients without invasive candidiasis at day 28 as compared to placebo. Other outcomes include day 28 and 90 survival and organ failure evolution. Additionally, pharmacokinetics of micafungin in enrolled patients will be measured and evolution of fungal biomarkers and susceptibility profiles of infecting fungi will also be followed. DISCUSSION: This study will help to provide guidelines for treating non-immunocompromized patients with fungal colonization multiple organ failure and sepsis of unknown origin.Trial registration: Clinicaltrials.gov number NCT01773876.
ISSN: 1745-6215

inserm-00913515
http://www.hal.inserm.fr/inserm-00913515
http://www.hal.inserm.fr/inserm-00913515/document
http://www.hal.inserm.fr/inserm-00913515/file/1745-6215-14-399.pdf
PUBMED : 24261608

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