(1 → 3)-β-D-Glucan-guided antifungal therapy in adults with sepsis: the CandiSep randomized clinical trial.

"Declarations Conflicts of interestFB received honoraria for an expert board meeting by Baxter. Prof. Cornely reports grants or contracts from Amplyx, Basilea, BMBF, Cidara, DZIF, EU-DG RTD (101037867), F2G, Gilead, Matinas, MedPace, MSD, Mundipharma, Octapharma, Pfizer, Scynexis; Consulting fees from Amplyx, Biocon, Biosys, Cidara, Da Volterra, Gilead, Matinas, MedPace, Menarini, Molecular Partners, MSG-ERC, Noxxon, Octapharma, PSI, Scynexis, Seres; Honoraria for lectures from Abbott, Al-Jazeera Pharmaceuticals, Astellas, Grupo Biotoscana/United Medical/Knight, Hikma, MedScape, MedUpdate, Merck/MSD, Mylan, Pfizer; Payment for expert testimony from Cidara; Participation on a Data Safety Monitoring Board or Advisory Board from Actelion, Allecra, Cidara, Entasis, IQVIA, Jannsen, MedPace, Paratek, PSI, Shionogi; A pending patent currently reviewed at the German Patent and Trade Mark Office; Other interests from DGHO, DGI, ECMM, ISHAM, MSG-ERC, Wiley. JH received grants and speaker honoraria from Pfizer, speaker honoraria from Gilead and consumables/test kits from Associates of Cape Cod. SK received research support from Cytosorbents and Daiichi Sankyo. He also received lecture fees from Astra, Bard, Baxter, Biotest, Cytosorbents, Daiichi Sankyo, Fresenius Medical Care, Gilead, Mitsubishi Tanabe Pharma, MSD, Pfizer, Philips and Zoll. He received consultant fees from Fresenius, Gilead, MSD and Pfizer. KK received honoraria for lecturing from Cytosorbents, Fresenius and Sedana. CP received lecture fees from Astra, C.R.Bard, Baxter, Biotest, Cytosorbents, Daiichi Sankyo, Fresenius, Gilead, Mitsubishi Tanabe Pharma, MSD, Pfizer, Philips and Zoll. He received consultant fees from Bayer, Fresenius, Gilead, MSD and Pfizer. He also received consultant fees from Messer, Pluristem, and Sedana and received lecture fees from Dräger Med. Inc. and Medronic. OM received honoraria for lectures during workshops on hemodynamic monitoring, supported by Pulsion (Maquet Critical Care) and for two lectures during industrial sessions at national congresses (HillRom, HepaWash); Unrestricted Research Grant from CSL Behring. DR has received support for attending meetings and/or travels from Gilead Sciences Inc., MSD, Pfizer. AW reported receiving honoraria for lecturing from Getinge and receiving personal fees from TEVA for consulting. No other disclosures were reported. Ethical approvalAll procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the Ethics Committee of the Jena University Hospital and by the responsible Ethics Committees of the participating study centers. Consent to participateWritten informed consent was obtained from all patients or their legal representatives, if available. In cases where consent could neither be obtained from the patient nor a legal representative in time before enrollment, the local ethics committee approved a delayed consent process. During this process the patient’s inability to provide consent was confirmed by an independent physician. As soon as the legal representative of the patient was available, written informed consent was immediately obtained, otherwise the patient was withdrawn from the study and all study procedures were ended. Consent for publicationNot applicable. Conflicts of interest FB received honoraria for an expert board meeting by Baxter. Prof. Cornely reports grants or contracts from Amplyx, Basilea, BMBF, Cidara, DZIF, EU-DG RTD (101037867), F2G, Gilead, Matinas, MedPace, MSD, Mundipharma, Octapharma, Pfizer, Scynexis; Consulting fees from Amplyx, Biocon, Biosys, Cidara, Da Volterra, Gilead, Matinas, MedPace, Menarini, Molecular Partners, MSG-ERC, Noxxon, Octapharma, PSI, Scynexis, Seres; Honoraria for lectures from Abbott, Al-Jazeera Pharmaceuticals, Astellas, Grupo Biotoscana/United Medical/Knight, Hikma, MedScape, MedUpdate, Merck/MSD, Mylan, Pfizer; Payment for expert testimony from Cidara; Participation on a Data Safety Monitoring Board or Advisory Board from Actelion, Allecra, Cidara, Entasis, IQVIA, Jannsen, MedPace, Paratek, PSI, Shionogi; A pending patent currently reviewed at the German Patent and Trade Mark Office; Other interests from DGHO, DGI, ECMM, ISHAM, MSG-ERC, Wiley. JH received grants and speaker honoraria from Pfizer, speaker honoraria from Gilead and consumables/test kits from Associates of Cape Cod. SK received research support from Cytosorbents and Daiichi Sankyo. He also received lecture fees from Astra, Bard, Baxter, Biotest, Cytosorbents, Daiichi Sankyo, Fresenius Medical Care, Gilead, Mitsubishi Tanabe Pharma, MSD, Pfizer, Philips and Zoll. He received consultant fees from Fresenius, Gilead, MSD and Pfizer. KK received honoraria for lecturing from Cytosorbents, Fresenius and Sedana. CP received lecture fees from Astra, C.R.Bard, Baxter, Biotest, Cytosorbents, Daiichi Sankyo, Fresenius, Gilead, Mitsubishi Tanabe Pharma, MSD, Pfizer, Philips and Zoll. He received consultant fees from Bayer, Fresenius, Gilead, MSD and Pfizer. He also received consultant fees from Messer, Pluristem, and Sedana and received lecture fees from Dräger Med. Inc. and Medronic. OM received honoraria for lectures during workshops on hemodynamic monitoring, supported by Pulsion (Maquet Critical Care) and for two lectures during industrial sessions at national congresses (HillRom, HepaWash); Unrestricted Research Grant from CSL Behring. DR has received support for attending meetings and/or travels from Gilead Sciences Inc., MSD, Pfizer. AW reported receiving honoraria for lecturing from Getinge and receiving personal fees from TEVA for consulting. No other disclosures were reported."

"Funding Open Access funding enabled and organized by Projekt DEAL. This trial was supported by a Grant (01EO1502) to the Jena University Hospital provided by the German Federal Ministry of Education and Research. The Fungitell®-assay was provided free of charge for this study by Associates of CapeCod, Inc., USA. Prof. Bauer is funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) under Germany’s Excellence Strategy–EXC 2051–Project-ID 390713860. Prof. Putensen is funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation)–Project-ID PU219/2-3."

"The CandiSep trial was an open, randomized, multicenter trial comparing a BDG-guided antifungal therapy versus standard of care in patients with sepsis and high risk for developing ICI conducted in 18 German intensive care units (eTable 1). The protocol has been published previously []. The ethics board of the Jena University Hospital, the corresponding institutional review boards of all participating centers and the Federal Institute for Drugs and Medical Devices approved the trial. The trial was registered at ClinicalTrials.gov (NCT02734550). Written informed consent was obtained from all patients or their legal representatives. The ethics committees approved a deferred consent for those patients unable to give informed consent but not having appointed a legal representative. As soon as the legal representative of the patient was available, written informed consent was obtained; otherwise, the patient was withdrawn from the study. Trial execution was overseen by an independent data and safety monitoring board."