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Article History

Received: 4 February 2025

Accepted: 25 July 2025

First Online: 19 August 2025

Declarations

:

: This clinical trial was designed, shall be implemented and reported in accordance with ICH GCP, with applicable regulations (including Regulation (EU) No. 536/2014), and with the ethical principles laid down in the Declaration of Helsinki.This clinical trial protocol has been approved via CTIS by Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) and the central ethics committee of the Trial on 31. May 2024. Prior to randomization, written informed consent will be obtained from the patients.

: The consent forms (2 versions depending on whether an MRI is desired by the patient or not and the consent for secondary use) and other related documentation will be given to participants (Additional files 1, 2 and 3).

: OAC reports grants or contracts from BMBF, Cidara, DZIF, EU-DG RTD, F2G, Gilead, MedPace, MSD, Mundipharma, Octapharma, Pfizer, Scynexis; Consulting fees from Abbvie, AiCuris, Basilea, Biocon, Boston Strategic Partners, Cidara, Seqirus, Gilead, GSK, IQVIA, Janssen, Matinas, MedPace, Menarini, Molecular Partners, MSG-ERC, Mundipharma, Noxxon, Octapharma, Pardes, Partner Therapeutics, Pfizer, PSI, Scynexis, Seres, Shionogi, The Prime Meridian Group, Elion Therapeutics, Menarini, Melinta; Speaker and lecture honoraria from Abbott, Abbvie, Akademie für Infektionsmedizin, Al-Jazeera Pharmaceuticals/Hikma, amedes, AstraZeneca, Deutscher Ärzteverlag, Gilead, GSK, Grupo Biotoscana/United Medical/Knight, Ipsen Pharma, Medscape/WebMD, MedUpdate, MSD, Moderna, Mundipharma, Noscendo, Paul-Martini-Stiftung, Pfizer, Sandoz, Seqirus, Shionogi, streamedup!, Touch Independent, Vitis; Payment for expert testimony Cidara; Participation on a DRC, DSMB, DMC, Advisory Board for Cidara, IQVIA, Janssen, MedPace, PSI, Pulmocide, Vedanta Biosciences, AstraZeneca, Melinta. MV reports grants or contracts from MSD, Heel, BioNTech, Roche, SD Biosensor, Tillotts; Consulting fees from Ferring, Tillotts, Bioaster; Speaker and lecture honoraria from Akademie für Ärztliche Fort- und Weiterbildung, Akadmie für Infektionsmedizin, Astra Zeneca, bioMerieux, DGI, EUMEDICA, European Society of Neurogastroenterology, Ferring, FomF GmbH, Förderkreis Malteser, Frankfurter Bürger Universität, GILEAD, GSK, Helios Kliniken, Hessisches Landessozialgericht, Janssen Cilag GmbH, Jörg Eikerle Beratung, Klinikum Leverkusen, Lahn-Dill Kliniken, Landesärztekammer Hessen, LMU Kliniken, Med. Gesellschaft Bad Homburg, MSD, Pfizer, St. Vincent Hospital, Tillotts. The other authors declare that they have no competing interests.