Home › Trials › NCT02979951

Using fosfomycin to treat severely infected patients

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.

Observational Infectopharm Arzneimittel GmbH · NCT02979951

This study is testing if an intravenous antibiotic called fosfomycin can safely help people with serious infections like osteomyelitis and bacterial meningitis feel better.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorInfectopharm Arzneimittel GmbH Industry-sponsored
Locations50 sites (Hall in Tirol and 49 other locations)
Trial IDNCT02979951 on ClinicalTrials.gov

What this trial studies

This European, multicentric, prospective, non-interventional study aims to document and evaluate the efficacy and safety of intravenously administered fosfomycin in severely infected patients. It includes individuals suffering from various serious infections such as osteomyelitis, complicated urinary tract infections, and bacterial meningitis. The study will monitor patients receiving fosfomycin treatment according to national guidelines, focusing on real-world outcomes. Data will be collected to assess the effectiveness and safety of this treatment approach in a diverse patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with severe bacterial infections who are being treated with fosfomycin.

Not a fit: Patients who may not benefit from this study include those with known hypersensitivity to fosfomycin, terminally ill patients, or those receiving palliative care.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of fosfomycin for treating severe bacterial infections, potentially improving patient outcomes.

How similar studies have performed: While this study is observational and builds on existing knowledge of fosfomycin, similar studies have shown promise in evaluating the efficacy of antibiotics in severe infections.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Hall in Tirol and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bacterial InfectionsBone Diseases, InfectiousOsteomyelitisCentral Nervous System Bacterial InfectionsMeningitis, BacterialEncephalitisBrain AbscessUrinary Tract Infections
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.