An observational study in Staphylococcal Aureus Infection and Staphylococcus Aureus Bacteraemia, sponsored by Hospital Universitari de Bellvitge. Active, not recruiting at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Hospital Universitari de Bellvitge · Observational
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.
Hospital Universitari de Bellvitge is the lead sponsor of 118 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The BACSAFO cohort pools individual participant data from two multicentre, randomised, superiority trials evaluating adjunctive fosfomycin for the treatment of SAB: BACSARM and SAFO. The BACSARM trial included 155 adult patients with methicillin-resistant (MRSA), randomised 1:1 to receive either daptomycin alone or daptomycin plus fosfomycin. The SAFO trial enrolled 214 adult patients with methicillin-susceptible (MSSA) bacteraemia, randomised to cloxacillin alone or cloxacillin plus fosfomycin.
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:
Common exclusion criteria for the BACSARM and SAFO RCTs:
Particular exclusion criteria for the BACSARM RCT:
Particular exclusion criteria for the SAFO RCT:
Patients with Staphylococcus aureus bacteraemia from the BACSAFO cohort treated with any regimen including fosfomycin
Patients with Staphylococcus aureus bacteraemia from the BACSAFO cohort treated with any regimen not containing fosfomycin
All-cause mortality at 60 days
All-cause mortality at 60 days after randomisation
Time frame: At 60 days from randomisation
All-cause mortality at 30 days
All-cause mortality at 30 days after randomisation
Time frame: At 30 days after randomisation
Treatment success at 8 weeks
Survival without clinical relapse and with resolution of symptoms at 8 weeks after randomisation
Time frame: At 8 weeks after randomisation
Plan to share: Yes — Raw anonymised data relating to primary and secondary outcomes and safety may be shared upon request with researchers who provide a methodologically reasonable proposal. Requests for data should be sent to the corresponding author (JC). Interested researchers must obtain the approval of the Bellvitge University Hospital Ethics Committee.
Supporting information: Study protocol, Sap, Csr
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Hospital Universitari de Bellvitge