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

NCT07155590 · tracked via the Priya Life Science Spain tracker

Sponsor

Hospital Universitari de Bellvitge

Phase

Observational

Started

2025-07-21

Last updated

2025-09-11

Condition(s) studied

Staphylococcal Aureus InfectionStaphylococcus Aureus Bacteraemia

Study summary

Staphylococcus aureus bacteraemia (SAB) is a major global cause of sepsis-related mortality. Randomised trials of adjunctive antibiotics, including fosfomycin, have not shown consistent benefit, possibly due to inclusion of unselected SAB populations. The FEN-AUREUS classification enables early risk stratification based on clinical subphenotypes. The investigators aim to validate this framework in a pooled trial cohort and assess whether combining subphenotypes with IDSA-defined complicated SAB could identify patients most likely to benefit from adjunctive fosfomycin. The investigators will conduct a post-hoc analysis of individual-level data from two multicentre randomised trials-BACSARM and SAFO-evaluating fosfomycin in SAB. Participants will be classified using FEN-AUREUS into source phenotypes (A, B and C) and risk subphenotypes (1 = low-risk, 2 = high-risk). Associations between subphenotype, treatment arm, and outcomes (30/60-day mortality, 8-week treatment success) will be assessed using multivariable models. Monte Carlo simulations will explore power by subgroup. FEN-AUREUS subphenotypes combined with complication status have the potential to identify patients with SAB that could likely benefit form combination therapy with fosfomycin.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion criteria for the present study: all patients included in the BACSAFO cohort, composed of all patients included in the intention-to-treat populations of the BACSARM and SAFO randomised clinical trials (RCT). Inclusion criteria for the BACSARM and SAFO RCTs: * \> or = 18 years old * Monomicrobial Staphylococcus aureus bacteraemia * Evidence of active infection Common exclusion criteria for the BACSARM and SAFO RCTs: * Polymicrobial bacteraemia * Severe clinical status with expected survival \< 24 hours * Severe liver disease with Child-Pugh score class C * Diagnosis of prosthetic infective endocarditis * Allergy or known resistance to study drugs * Pregnancy at the time of inclusion * Inclusion in another clinical trial Particular exclusion criteria for the BACSARM RCT: * Diagnosis of MRSA pneumonia * Prior history of eosinophilic pneumonia * Use of additional antibiotic therapy with microbiological activity against MRSA Particular exclusion criteria for the SAFO RCT: * Prior history of myasthenia gravis * Acute SARS-CoV2 infection

Primary outcome measure(s)

All-cause mortality at 60 days — At 60 days from randomisation
All-cause mortality at 60 days after randomisation

Trial sites (2)

Facility	City	Region	Status
Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Catalonia
Hospital Universitario Virgen de Macarena	Seville	Spain

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07155590 on ClinicalTrials.gov ↗ ← All trials in Spain