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

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio

Observacional

Fase

No aplica / no indicada

Rango de edad

18 años - No especificado

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

120 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

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.

¿Quién podría participar?

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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.

Población del estudio

Patients affected by infective endocarditis

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

No informado

Enmascaramiento

No informado

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Centros de investigación (0)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

No hay centros indicados. Usa el contacto oficial del estudio.

Equipo y fechas

Patrocinador principal

Ente Ospedaliero Ospedali Galliera

Inicio del estudio

10 ene 2027 Estimado

Finalización primaria

31 dic 2029 Estimado

Finalización del estudio

30 jun 2030 Estimado

Primera publicación

10 nov 2026 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.