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Article History

Received: 11 March 2025

Accepted: 14 October 2025

First Online: 12 November 2025

Declarations

:

: The study protocol will be reviewed by each site’s relevant local IRB prior to participation. We will request a waiver of informed consent from each site. If local and/or national regulations do not allow a waiver of consent, a locally approved consent process will be utilized. To ensure subject confidentiality and privacy, database access will be limited to study personnel who are issued a unique user identification and password. Data will be entered at each site by study personnel. The study protocol, documentation, data, and all other information generated will be held in strict confidence.

: Consent for publication was sought and approved by all listed authors who have no objection to its presentation and/or publication. The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting true views of the sponsor. The investigators have adhered to the policies for the protection of human subjects as prescribed in AR 70–25.

: The authors report the following outside financial activities:Dr. Patel reports grants from MicuRx Pharmaceuticals and bioMérieux. Dr. Patel is a consultant to PhAST, Day Zero Diagnostics, DEEPULL DIAGNOSTICS, S.L., HealthTrackRx, bioMérieux and CARB-X. In addition, Dr. Patel has a patent on Bordetella pertussis/parapertussis PCR issued, a patent on a device/method for sonication, and a patent on an anti-biofilm substance issued. Dr. Patel receives honoraria from Up-to-Date and the Infectious Diseases Board Review Course. Dr. Doernberg reports grants from Gilead, Pfizer, F2G, Regeneron, Chan Zuckerberg Biohub, PCORI, and NIAID/NIH and is a consultant to Genentech, Janssen, Shinogi, and Basilea. Dr. Doernberg has a patent on therapeutic use of a Mif agonist. Dr. Evans reports grants from NIH and the Centers for Disease Control and Prevention and receives consulting fees from Genentech, AstraZeneca, Takeda, Microbiotix, Johnson &Johnson, Endologix, ChemoCentryx, Becton Dickenson, Atricure, Roivant, Neovasc, Nobel Pharma, Horizon, International Drug Develoment Institute, SVB Leerink, Medtronic, Regeneron, Wake Forest University, Recor, Janssen, and IDDI, and honoraria from Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) and the U.S. Food and Drug Administration. Dr. Evans participates in Data Safety and Monitoring Boards or Advisory Boards for NIH, BARDA, Breast International Group, University of Pennsylvania, Washington University, Duke University, Roche, Pfizer, Takeda, Akouos, Apellis, Teva, Vir, DayOneBio, Alexion, Tracon, Rakuten, Abbvie, GSK, Eli Lilly, Nuvelution, Clover, FHI Clinical, Lung Biotech, SAB Biopharm, Advantagene, Candel, and Novartis. Dr. Fowler reports grants from NIH, Merck, Contrafect, Karius, Basilea, Janssen, AstraZeneca, and EDE. He receives honoraria from Up-to-Date, consulting fees from Akagera, AstraZeneca, Armata, Basilea, Debiopharm, GSK, and Integrated Biotherapeutics, has a patent on a sepsis diagnostic, and stock options in Valanbio. All other authors declare no conflicts of interest. The trial design was not affected by any external relationships with companies.