Study of Fosfomycin-containing Antibiotic Regimens for the Treatment of Infective Endocarditis in Clinical Practice

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

120 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

A prospective, multicenter, non-interventional, observational cohort study on the use of a pharmacological agent, conducted within Infectious Diseases units-and, where available, as part of multidisciplinary teams for infective endocarditis-selected according to predefined feasibility criteria. Enrollment will be consecutive and will include all eligible patients for whom fosfomycin has already been initiated, or is initiated by the treating clinician, as part of routine clinical practice.

The decision to prescribe fosfomycin, the dosage, antibiotic combinations, duration of treatment, diagnostic tests, and any potential cardiac surgery strategy will remain entirely independent of the study and subject to local clinical judgment.

The study population will consist of adult patients with a diagnosis of definite or probable infective endocarditis, according to the 2023 Duke-ISCVID criteria, who have received at least one dose of intravenous (IV) fosfomycin as part of the antibiotic regimen for the clinical episode under observation. The availability of the minimum set of clinical, therapeutic, and microbiological data required by the protocol is a necessary requirement for inclusion.

Primary objective To describe the overall clinical outcomes and safety profile of fosfomycin-containing antibiotic regimens used in clinical practice for the treatment of infective endocarditis, assessed by the proportion of overall therapeutic success at a predefined 90-day follow-up and the incidence of adverse events of interest.

Secondary objectives To describe the methods of fosfomycin use in this setting, including clinical indication, timing of initiation, dosage, duration, combination agents, and the rationale behind the therapeutic choice.

To describe the clinical, microbiological, echocardiographic, and imaging characteristics of the enrolled patients.

To evaluate early and late microbiological outcomes, including blood culture clearance, persistence of bacteremia, microbiological recurrence, emergence of resistance, and relapse.

To describe the safety profile of fosfomycin, with particular attention to sodium overload, hypokalemia, electrolyte imbalances, renal toxicity, and adverse events leading to modification or discontinuation of treatment.

To explore the association between patterns of fosfomycin use and clinical or microbiological outcomes, without the intent of establishing causal inference.

To describe microbiological data related to fosfomycin in a standardized manner, specifying the raw MIC value, the antimicrobial susceptibility testing (AST) method, the interpretive criteria applied, and whether or not categorization according to applicable clinical breakpoints is possible.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Age ≥18 years.
• Diagnosis of definite or possible infective endocarditis according to the 2023 Duke-ISCVID criteria.
• Administration of at least one dose of intravenous (IV) fosfomycin as part of the antibiotic regimen for the episode of infective endocarditis under study.
• Decision to initiate fosfomycin based solely on clinical grounds, independent of participation in the study.
• Availability of the minimum set of clinical, therapeutic, and microbiological data required by the protocol.

Exclusion Criteria:

• Case that cannot be classified as definite or probable infective endocarditis according to the 2023 Duke-ISCVID criteria.
• Use of fosfomycin for indications unrelated to the episode of infective endocarditis under study.
• Substantial inability to collect essential baseline or outcome data.
• Refusal of consent, where required by applicable regulations.

Study population

Patients affected by infective endocarditis

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (0)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

No locations are listed. Use the official study contact.

Study team and timeline

Lead sponsor

Ente Ospedaliero Ospedali Galliera

Study start

Jan 10, 2027 Estimated

Primary completion

Dec 31, 2029 Estimated

Study completion

Jun 30, 2030 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.