MedDataX Logo

Fosfomycin I.v. for Treatment of Severely Infected Patients

NCT ID: NCT02979951

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2030-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assessment of the Efficacy of FOSFOMYCIN in Patients With Bacterial Infection

NCT01173575

Bacterial Infection
COMPLETED

Study Comparing Nitrofurantoin to Fosfomycin for Acute Urinary Tract Infection in Women

NCT01966653

Urinary Tract Infections Cystitis
UNKNOWN PHASE4

Fosfomycin Versus Meropenem or Ceftriaxone in Bacteriemic Infections Caused by Multidrug Resistance in E.Coli

NCT02142751

Infection Due to ESBL Escherichia Coli
COMPLETED PHASE3

A Combination Therapy With Ceftazidime and Fosfomycin Will be Compared to Ceftazidime Alone in Hospitalized Adult Patients With Suspected Severe Gram-negative Bacterial Infections

NCT07063095

Gram Negative Infections Sepsis and Septic Shock
RECRUITING PHASE3

Subphenotype- and Complication-guided Adjunctive Fosfomycin Therapy for Staphylococcus Aureus Bacteraemia

NCT07155590

Staphylococcal Aureus Infection Staphylococcus Aureus Bacteraemia
ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bacterial Infections Bone Diseases, Infectious Osteomyelitis Central Nervous System Bacterial Infections Meningitis, Bacterial Encephalitis Brain Abscess Urinary Tract Infections Respiratory Tract Infections Pneumonia, Bacterial Skin Diseases, Bacterial Soft Tissue Infections Intraabdominal Infections Sepsis Bacteremia Endocarditis, Bacterial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

INPADS GmbH

UNKNOWN

Sponsor Role collaborator

Dr. Oestreich + Partner GmbH

UNKNOWN

Sponsor Role collaborator

Infectopharm Arzneimittel GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Klaus-Friedrich Bodmann, Dr.

Role: STUDY_DIRECTOR

Klinik Nordoberpfalz AG, Klinikum Weiden

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Landeskrankenhaus Hall - Tirol Kliniken

Hall in Tirol, , Austria

Site Status RECRUITING

A.ö. Bezirkskrankenhaus

Reutte, , Austria

Site Status RECRUITING

AKH Wien, Universitätsklinik für Innere Medizin 1

Vienna, , Austria

Site Status RECRUITING

Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie

Wels, , Austria

Site Status RECRUITING

Universitätsmedizin Charité

Berlin, , Germany

Site Status COMPLETED

Vivantes Kliniken Neukölln

Berlin, , Germany

Site Status RECRUITING

Städtisches Klinikum Braunschweig

Braunschweig, , Germany

Site Status RECRUITING

Universitäts Düsseldorf; Klinik für Anästhesiologie

Düsseldorf, , Germany

Site Status COMPLETED

Universitätsklinikum Frankfurt

Frankfurt, , Germany

Site Status RECRUITING

Universität Hamburg-Eppendorf

Hamburg, , Germany

Site Status RECRUITING

Universitätsklinikum Jena; Zentrum für Infektionsmedizin

Jena, , Germany

Site Status RECRUITING

Universitätsklinikum Schleswig-Holstein

Kiel, , Germany

Site Status RECRUITING

Universitätsklinik Schleswig-Holstein

Lübeck, , Germany

Site Status RECRUITING

LMU München

München, , Germany

Site Status RECRUITING

Universitätsklinikum Münster

Münster, , Germany

Site Status RECRUITING

Klinikum Oldenburg

Oldenburg in Holstein, , Germany

Site Status RECRUITING

Universitätsklinik Regensburg; Klinik für Anästhesiologie

Regensburg, , Germany

Site Status RECRUITING

Kliniken Nordoberpfalz

Weiden, , Germany

Site Status COMPLETED

General Oncology Hospital of Kifissia "Agioi Anargiroi"

Kifissia, Athens, Greece

Site Status RECRUITING

General Hospital of Athens "Evangelismos"

Athens, , Greece

Site Status RECRUITING

Sotiria Thoracic Diseases Hospital of Athens

Athens, , Greece

Site Status RECRUITING

University General Hospital "ATTIKON"

Athens, , Greece

Site Status RECRUITING

General Hospital of Attica "KAT"

Kifissia, , Greece

Site Status RECRUITING

General Hospital of Lamia

Lamia, , Greece

Site Status RECRUITING

RIO Univ. Hospital, Dept of Pathology, Division of Infectious Diseases

Pátrai, , Greece

Site Status RECRUITING

"AHEPA" University General Hospital of Thessaloniki

Thessaloniki, , Greece

Site Status RECRUITING

General Hospital of Thessaloniki "G. GENIMMATAS"

Thessaloniki, , Greece

Site Status RECRUITING

General Hospital of Thessaloniki "Hippokration"

Thessaloniki, , Greece

Site Status RECRUITING

General Hospital of Thessaloniki "G. Papanikolaou"

Thessaloniki, , Greece

Site Status RECRUITING

Clinical Malattie Infettive

Bari, , Italy

Site Status RECRUITING

Azienda Ospedaliera S.Croce e Carle

Cuneo, , Italy

Site Status RECRUITING

Ospedal Policlinico San Martino

Genova, , Italy

Site Status RECRUITING

Ospedale L. Sacco

Milan, , Italy

Site Status ACTIVE_NOT_RECRUITING

Istituto Mediterraneo per i Trapianti Ismett IRCCS

Palermo, , Italy

Site Status RECRUITING

Policlinico Paolo Giaccone

Palermo, , Italy

Site Status RECRUITING

Policlinico Umberto I, Malattie Infettive

Rome, , Italy

Site Status RECRUITING

Lazzaro Spallanzani

Rome, , Italy

Site Status RECRUITING

Polocinico Tor Vergata

Rome, , Italy

Site Status RECRUITING

AOU Città della Salute e Scienza-Presidio Molinette

Torino, , Italy

Site Status RECRUITING

Ospedale S.M.della Misericordia

Udine, , Italy

Site Status RECRUITING

ASST-Sette Lagh Viale Borre

Varese, , Italy

Site Status RECRUITING

Royal Bolton Hospital

Bolton, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Hull & East Yorkshire Hospitals NHS Trust

Cottingham, , United Kingdom

Site Status RECRUITING

Ninewells Hospital

Dundee, , United Kingdom

Site Status RECRUITING

Queen Elisabeth University Hospital

Glasgow, , United Kingdom

Site Status RECRUITING

University of Glasgow/Royal Infirmary

Glasgow, , United Kingdom

Site Status RECRUITING

University Hospital Crosshouse

Kilmarnock, , United Kingdom

Site Status RECRUITING

Chelsea & Westminster Hospial

London, , United Kingdom

Site Status RECRUITING

Queen Elisabeth Hospital

London, , United Kingdom

Site Status RECRUITING

Univresity College Londen (UCL) Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Austria Germany Greece Italy United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Thomas Borrmann, Dr.

Role: CONTACT

[email protected]

Katja Eifert

Role: CONTACT

[email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ivo Graziadei, MD

Role: primary

Eugen Ladner, MD

Role: primary

Matthias Vossen, MD

Role: primary

Rainer Gattringer, MD

Role: primary

Herwig Gerlach, Prof.

Role: primary

Jan Kielstein, Dr.

Role: primary

Simone Lindau

Role: primary

Stefan Kluge, Prof.

Role: primary

Mathias Pletz, Prof.

Role: primary

Dirk Schädler, Prof.

Role: primary

Jan Rupp, Prof.

Role: primary

Michael Zoller, Dr.

Role: primary

Sebastian Kintrup, MD

Role: primary

Ulf Günther, PD

Role: primary

Martin Kieninger, Dr. med.

Role: primary

Pavlos Myrianthefs, MD

Role: primary

Anastasia Kotanidou, MD

Role: primary

[email protected]
+30 6974508199

Georgios Dimopoulos, MD

Role: primary

Evangelos I. Giamarellos, MD

Role: primary

[email protected]
+30 6932905547

Ioannis Alamanos, MD

Role: primary

Fotios Tsimpoukas, MD

Role: primary

[email protected]
+30 6932766976

Markos Marangos, MD

Role: primary

Aikaterini Efthimiou, MD

Role: primary

[email protected]
+30 6974091279

Areti Karapanagiotou, MD

Role: primary

[email protected]

Eleni Mouloudi, MD

Role: primary

Nikolaos Kapravelos, MD

Role: primary

Davide Bavaro, MD

Role: primary

Valerio Del Bono, MD

Role: primary

Matteo Basetti, MD

Role: primary

Alessandra Mularoni, MD

Role: primary

Antonio Cascio, MD

Role: primary

Mario Venditti, MD

Role: primary

Alessandro Capone, MD

Role: primary

Loredana Sarmati, MD

Role: primary

Francesco G. De Rosa, MD

Role: primary

Carlo Tascini, MD

Role: primary

Paolo A. Grossi, MD

Role: primary

Gavin Barlow, MD

Role: primary

Benjamin Parcell, MD

Role: primary

Abhijit Bal, MD

Role: primary

Michael E Murphy, MD

Role: primary

Sam Allen, MD

Role: primary

Luke Moore, MD

Role: primary

Jorge Cepeda, MD

Role: primary

Giovanni Satta, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Bodmann 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.

Reference Type DERIVED
PMID: 40106180 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FORTRESS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Clinical Impact of Fluoroquinolone Resistance in Bacteremia Caused by Gram-Negative Bacilli of Urinary Tract Origin
NCT00414362 COMPLETED
Use of Fosfomycin in the Treatment of Bacterial Infections
NCT06814899 RECRUITING
Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis
NCT00871104 COMPLETED PHASE4
Discontinuation of Antibiotic Susceptibility Testing on Enterococcus Faecalis Positive Urine Cultures in Hospitalized Patients: an Impact on Antibiotic Prescriptions? (FaecaCible)
NCT05743192 COMPLETED
Pharmacological Study of High Doses of Ceftriaxone in Meningitidis
NCT01745679 COMPLETED PHASE4
Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections
NCT01281462 COMPLETED PHASE2
Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli (OVERCOME)
NCT01597973 COMPLETED PHASE3
Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit
NCT05696093 RECRUITING PHASE3
Colistin Versus Colistin Plus Fosfomycin for Infections Caused by MDR Acinetobacter Baumannii
NCT01297894 UNKNOWN PHASE3
Population Pharmacokinetic Study of Colistin in Patients Infected With Multiresistant Gram-negative Bacteria
NCT01060891 COMPLETED PHASE1
Effect of Antibiotic Choice On ReNal Outcomes (ACORN)
NCT05094154 COMPLETED PHASE4
Subcutaneous Daptomycin in Healthy Volunteers (DAPTOSC)
NCT04434300 COMPLETED PHASE1
NCCR AntiResist:: New Approaches to Combat Antibiotic-resistant Bacteria
NCT05017766 RECRUITING
Evaluation of the Non-inferiority of Cefoxitin Versus Imipenem/Cilastatin in the Treatment of Urinary Tract Infections Caused by ESBL-producing Escherichia Coli
NCT02474706 TERMINATED PHASE4
Antimicrobial Therapy for Difficult-to-treat Pseudomonas Aeruginosa
NCT06738771 RECRUITING
Colistin Intravenous Administration in Critically Ill Patients Suffering From Hospital Infections Caused by Multi-antibiotic-resistant Germs.
NCT04995133 UNKNOWN PHASE4
Intravenous Fosfomycin Pharmacokinetics Study
NCT03910673 COMPLETED PHASE1
Intravenous and Oral Fosfomycin in Hospitalised Neonates With Clinical Sepsis
NCT03453177 COMPLETED PHASE2
Selective Reporting of Antibiotic Susceptibility Test Results in Urinary Tract Infections in the Outpatient Setting
NCT03612297 UNKNOWN
Treatment of Enterococcus Faecalis Bacterem
NCT07299539 RECRUITING
Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections
NCT02569541 COMPLETED PHASE2/PHASE3
Emergence of Fluoroquinolone Resistance in Commensal Flora
NCT01209247 COMPLETED NA
Retrospective Observational Study of Cotrimoxazole Dosing in Intensive Care Unit
NCT05221216 COMPLETED
New AntiBiotic Treatment Options for Uncomplicated Anogenital GOnorrhoea
NCT03294395 COMPLETED PHASE3
Efficacy of Temocillin in Urinary Tract Infection Due to ESBL Producing and AmpC Hyperproducing Enterobacteriaceae
NCT02681263 UNKNOWN PHASE4