Bacterial InfectionsFORTRESSNCT02979951
Fosfomycin I.v. for Treatment of Severely Infected Patients
An observational study of Bacterial Infections and Bone Diseases, Infectious, run by Infectopharm Arzneimittel GmbH at 50 sites in 5 countries.
Trial summary
The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin, including patients with osteomyelitis, complicated urinary tract infection, nosocomial lower… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infections, Bone Diseases, Infectious, Osteomyelitis
- How many people
- 1,000 participants
- Where
- 50 sitesin 5 countries
- Study dates
- Dec 2016to Dec 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients of the participating study sites (clinics specialised and experienced in the management and treatment of patients suffering from (a part of) the included diseases as mentioned in the respective inclusion criterion), who fulfill all inclusion criteria and do not fulfill any of the exclusion criteria, are eligible for participation in the FORTRESS study.
Who may be able to join
- Male or female patients aged ≥ 18 years
- Treatment with fosfomycin according to the (national) Summary of Product Characteristics (SmPC) of fosfomycin i.v.
- Patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue infection, endocarditis or other infection, each as far as covered by the respective nationally relevant SmPC
- Written informed consent of the participant (or person in charge in case of patients incapable of giving consent)
Who cannot join
- Previous documentation of the patient in the present study
- Patients participating in an interventional clinical trial
- Patients with known hypersensitivity to fosfomycin or any of the excipients
- Terminally ill patients
- Patients with "do not resuscitate order"
- Palliative treatment approach
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- Failure of > 3 of the following organ systems: respiratory system, nervous system, cardiovascular system, liver, coagulation, kidney
- Manifest Human Immunodeficiency Virus (HIV) disease (Acquired Immunodeficiency Syndrome, AIDS)
- Fosfomycin treatment as 4th line treatment or at later stage
- Patients with involvement of fungi or mycobacteria in the targeted infection
Trial locations and contacts
50 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Thomas Borrmann, Dr. contact
Katja Eifert contact
50 sites in 5 countries
Germany14 sites, 11 recruiting
- Completed
Universitätsmedizin Charité
Berlin, 10177
- Recruiting
Vivantes Kliniken Neukölln
Berlin, 12351
Herwig Gerlach, Prof.
- Recruiting
Städtisches Klinikum Braunschweig
Braunschweig, 38126
Jan Kielstein, Dr.
- Completed
Universitäts Düsseldorf; Klinik für Anästhesiologie
Düsseldorf, 40225
- Recruiting
Universitätsklinikum Frankfurt
Frankfurt
Simone Lindau
- Recruiting
Universität Hamburg-Eppendorf
Hamburg, 20251
Stefan Kluge, Prof.
- Recruiting
Universitätsklinikum Jena; Zentrum für Infektionsmedizin
Jena, 07740
Mathias Pletz, Prof.
- Recruiting
Universitätsklinikum Schleswig-Holstein
Kiel
Dirk Schädler, Prof.
- Recruiting
Universitätsklinik Schleswig-Holstein
Lübeck, 23538
Jan Rupp, Prof.
- Recruiting
LMU München
München, 81377
Michael Zoller, Dr.
- Recruiting
Universitätsklinikum Münster
Münster, 40149
Sebastian Kintrup, MD
- Recruiting
Klinikum Oldenburg
Oldenburg in Holstein
Ulf Günther, PD
- Recruiting
Universitätsklinik Regensburg; Klinik für Anästhesiologie
Regensburg, 93053
Martin Kieninger, Dr. med.
- Completed
Kliniken Nordoberpfalz
Weiden, 92637
Italy12 sites, 11 recruiting
- Recruiting
Clinical Malattie Infettive
Bari, 70124
Davide Bavaro, MD
- Recruiting
Azienda Ospedaliera S.Croce e Carle
Cuneo
Valerio Del Bono, MD
- Recruiting
Ospedal Policlinico San Martino
Genova
Matteo Basetti, MD
- Active, not recruiting
Ospedale L. Sacco
Milan
- Recruiting
Istituto Mediterraneo per i Trapianti Ismett IRCCS
Palermo
Alessandra Mularoni, MD
- Recruiting
Policlinico Paolo Giaccone
Palermo
Antonio Cascio, MD
- Recruiting
Policlinico Umberto I, Malattie Infettive
Rome, 00161
Mario Venditti, MD
- Recruiting
Lazzaro Spallanzani
Rome
Alessandro Capone, MD
- Recruiting
Polocinico Tor Vergata
Rome
Loredana Sarmati, MD
- Recruiting
AOU Città della Salute e Scienza-Presidio Molinette
Torino
Francesco G. De Rosa, MD
- Recruiting
Ospedale S.M.della Misericordia
Udine
Carlo Tascini, MD
- Recruiting
ASST-Sette Lagh Viale Borre
Varese
Paolo A. Grossi, MD
Greece11 sites, 11 recruiting
- Recruiting
General Hospital of Athens "Evangelismos"
Athens
Anastasia Kotanidou, MD, +30 6974508199, akotanid@med.uoa.gr
- Recruiting
Sotiria Thoracic Diseases Hospital of Athens
Athens
Georgios Dimopoulos, MD
- Recruiting
University General Hospital "ATTIKON"
Athens
Evangelos I. Giamarellos, MD, +30 6932905547, egiamarel@med.uoa.gr
- Recruiting
General Oncology Hospital of Kifissia "Agioi Anargiroi"
Kifissia, Athens
Pavlos Myrianthefs, MD
- Recruiting
General Hospital of Attica "KAT"
Kifissia
Ioannis Alamanos, MD
- Recruiting
General Hospital of Lamia
Lamia
Fotios Tsimpoukas, MD, +30 6932766976, ftsimpoukas@yahoo.gr
- Recruiting
RIO Univ. Hospital, Dept of Pathology, Division of Infectious Diseases
Pátrai
Markos Marangos, MD
- Recruiting
"AHEPA" University General Hospital of Thessaloniki
Thessaloniki
Aikaterini Efthimiou, MD, +30 6974091279, efthka@gmail.com
- Recruiting
General Hospital of Thessaloniki "G. GENIMMATAS"
Thessaloniki
Areti Karapanagiotou, MD, aretikarapan@gmail.com
- Recruiting
General Hospital of Thessaloniki "Hippokration"
Thessaloniki
Eleni Mouloudi, MD
- Recruiting
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki
Nikolaos Kapravelos, MD
United Kingdom9 sites, 8 recruiting
- Active, not recruiting
Royal Bolton Hospital
Bolton, BL4 0JR
- Recruiting
Hull & East Yorkshire Hospitals NHS Trust
Cottingham, HU16 5JQ
Gavin Barlow, MD
- Recruiting
Ninewells Hospital
Dundee, DD1 9SY
Benjamin Parcell, MD
- Recruiting
Queen Elisabeth University Hospital
Glasgow
Abhijit Bal, MD
- Recruiting
University of Glasgow/Royal Infirmary
Glasgow
Michael E Murphy, MD
- Recruiting
University Hospital Crosshouse
Kilmarnock, KA2OBB
Sam Allen, MD
- Recruiting
Chelsea & Westminster Hospial
London
Luke Moore, MD
- Recruiting
Queen Elisabeth Hospital
London
Jorge Cepeda, MD
- Recruiting
Univresity College Londen (UCL) Hospital
London
Giovanni Satta, MD
Austria4 sites, 4 recruiting
- Recruiting
Landeskrankenhaus Hall - Tirol Kliniken
Hall in Tirol
Ivo Graziadei, MD
- Recruiting
A.ö. Bezirkskrankenhaus
Reutte
Eugen Ladner, MD
- Recruiting
AKH Wien, Universitätsklinik für Innere Medizin 1
Vienna
Matthias Vossen, MD
- Recruiting
Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie
Wels
Rainer Gattringer, MD
About this study
Official title: An International, Multicentre, Non-comparative, Non-interventional, Prospective Clinical Registry to Evaluate the Clinical Outcome and Safety of the Treatment of Severely Infected Patients with Fosfomycin I.v.
The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin, including patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue infection, endocarditis or other infections, each as far as covered by the respective nationally relevant SmPC.
- Conditions
- Bacterial Infections, Bone Diseases, Infectious, Osteomyelitis, Central Nervous System Bacterial Infections, Meningitis, Bacterial, Encephalitis
- Keywords
- Observational Study, Non-Interventional Study, Registries, Prospective, Monitored, Multicentric, International, Fosfomycin, Infectofos, Fomicyt, Bacterial Infections, Gram-Negative Bacterial Infections, Gram-Positive Bacterial Infections, Bone Diseases, Infectious, Osteomyelitis, Central Nervous System Bacterial Infections, Meningitis, Bacterial, Encephalitis, Brain Abscess, Urinary Tract Infections
- Medical subject headings
- Bacterial Infections, Bone Diseases, Infectious, Osteomyelitis, Central Nervous System Bacterial Infections, Meningitis, Bacterial, Encephalitis, Brain Abscess, Urinary Tract Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with clinical success as defined as clinical cure or clinical improvement
Definition of clinical cure (both criteria must be fulfilled):
- Resolution of signs and symptoms and
- microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of clinical improvement (both criteria must be fulfilled):
- Partial resolution of signs and symptoms and
- microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
- Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
- in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "End of fosfomycin treatment" (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase).
Measured: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)
Secondary outcomes (23)
Microbiological cure
Definition of microbiological cure:
- Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
- in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "initial response" is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment.
Measured: Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)
Microbiological cure
Definition of microbiological cure:
- Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
- in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "End of fosfomycin treatment" (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase).
Measured: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)
Microbiological cure
Definition of microbiological cure:
- Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
- in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.
Measured: Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)
Microbiological cure
Definition of microbiological cure:
- Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
- in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.
Measured: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")
Clinical success as defined as clinical cure or clinical improvement
Definition of clinical cure (both criteria must be fulfilled):
- Resolution of signs and symptoms and
- microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of clinical improvement (both criteria must be fulfilled):
- Partial resolution of signs and symptoms and
- microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
- Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
- in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "initial response" is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment.
Measured: Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)
Clinical success as defined as clinical cure or clinical improvement
Definition of clinical cure (both criteria must be fulfilled):
- Resolution of signs and symptoms and
- microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of clinical improvement (both criteria must be fulfilled):
- Partial resolution of signs and symptoms and
- microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
- Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
- in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.
Measured: Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)
Clinical success as defined as clinical cure or clinical improvement
Definition of clinical cure (both criteria must be fulfilled):
- Resolution of signs and symptoms and
- microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of clinical improvement (both criteria must be fulfilled):
- Partial resolution of signs and symptoms and
- microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
- Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
- in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.
Measured: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")
Clinical cure
Definition of clinical cure (both criteria must be fulfilled):
- Resolution of signs and symptoms and
- microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
- Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
- in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "End of fosfomycin treatment" (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase).
Measured: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)
Clinical cure
Definition of clinical cure (both criteria must be fulfilled):
- Resolution of signs and symptoms and
- microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
- Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
- in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.
Measured: Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)
Clinical cure
Definition of clinical cure (both criteria must be fulfilled):
- Resolution of signs and symptoms and
- microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
- Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
- in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.
Measured: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")
Clinical improvement
Definition of clinical improvement (both criteria must be fulfilled):
- Partial resolution of signs and symptoms and
- microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
- Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
- in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "initial response" is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment.
Measured: Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)
Clinical improvement
Definition of clinical improvement (both criteria must be fulfilled):
- Partial resolution of signs and symptoms and
- microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
- Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
- in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "End of fosfomycin treatment" (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase).
Measured: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)
Clinical improvement
Definition of clinical improvement (both criteria must be fulfilled):
- Partial resolution of signs and symptoms and
- microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
- Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
- in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.
Measured: Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)
Clinical improvement
Definition of clinical improvement (both criteria must be fulfilled):
- Partial resolution of signs and symptoms and
- microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
- Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
- in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.
Measured: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")
Sodium serum levels
Measured: On every day from start of fosfomycin treatment until end of hospital stay (up to 6 months after start of fosfomycin treatment)
Potassium serum levels
Measured: On every day from start of fosfomycin treatment until end of hospital stay (up to 6 months after start of fosfomycin treatment)
Adverse events
Measured: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
Non-serious adverse events
Measured: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
Serious adverse events
Measured: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
Cases of death
Measured: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
Adverse drug reactions (ADRs)
Measured: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
Serious adverse drug reactions (SADRs)
Measured: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
Dropouts due to treatment failure or due to adverse events
Measured: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Infectopharm Arzneimittel GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INPADS GmbH, Dr. Oestreich + Partner GmbH
- Responsible party
- Sponsor
- Investigators
- Klaus-Friedrich Bodmann, Dr., Study director, Klinik Nordoberpfalz AG, Klinikum Weiden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979951
- Sponsor's protocol ID
- FORTRESS
- Acronym
- FORTRESS
- Status last verified
- Sep 2024
- First submitted
- 24 Nov 2016
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jarczak D, Kluge S, Kieninger M, Hagel S, Pletz MW, Zoller M, Spies C, Kintrup S, Antonitsch L, Zundel J, Del Bono V, Galfo V, Falcone M, Iasonidou C, Sarmati L, Campogiani L, Bal AM, Dimopoulos G, Vossen MG, Mastroianni CM, Bodmann KF, Herbst C, Mayer C; FORTRESS Study Group. Real-World Data on the Use of Intravenous Fosfomycin for the Treatment of Central Nervous System Infections: a Subgroup Analysis from the FORTRESS Study. Infect Dis Ther. 2026 Aug;15(8):2145-2165. doi: 10.1007/s40121-026-01383-8. Epub 2026 Jun 13.
PubMed 42286374Bodmann KF, Hagel S, Oliva A, Kluge S, Mularoni A, Galfo V, Falcone M, Pletz MW, Lindau S, Kading N, Kielstein JT, Zoller M, Tascini C, Kintrup S, Schadler D, Spies C, De Rosa FG, Radnoti S, Bandera A, Luzzati R, Allen S, Sarmati L, Cascio A, Kapravelos N, Subudhi CPK, Dimopoulos G, Vossen MG, Bal AM, Venditti M, Mastroianni CM, Borrmann T, Mayer C. Real-World Use, Effectiveness, and Safety of Intravenous Fosfomycin: The FORTRESS Study. Infect Dis Ther. 2025 Apr;14(4):765-791. doi: 10.1007/s40121-025-01125-2. Epub 2025 Mar 19.
PubMed 40106180