NCT07155590|Active Not Recruiting
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Sponsor study identifier
observational
369
1 country
2
Study Start
July 21, 2025
Actual (reported)Primary Completion
August 4, 2025
Actual (reported)Study Completion
September 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 21, 2025
Actual (reported)August 4, 2025
Actual (reported)August 27, 2025
Actual (reported)September 4, 2025
Actual (reported)September 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
All-cause mortality at 60 days
All-cause mortality at 60 days after randomisation
At 60 days from randomisation
All-cause mortality at 30 days
At 30 days after randomisation
Treatment success at 8 weeks
At 8 weeks after randomisation
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
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.
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Catalonia, 08907, Spain
Hospital Universitario Virgen de Macarena
Seville, 41009, Spain
Escrihuela-Vidal F, Larrauri JG, Lopez-Contreras J, Euba G, Vazquez A, Gomez-Zorrilla S, Lopez-Cortes LE, Gasch O, Aparicio-Minguijon E, Escudero-Sanchez R, Perez-Rodriguez MT, Rodriguez-Pardo D, Jover-Saenz A, Garcia-Pardo G, Rodriguez-Bano J, Pujol M, Carratala J, Gutierrez-Gutierrez B; BACSAFO/FEN-AUREUS Group. Subphenotype- and complication-guided adjunctive fosfomycin versus standard monotherapy in Staphylococcus aureus bacteraemia: pooled analysis of two randomised trials. Lancet Reg Health Eur. 2026 Feb 17;62:101611. doi: 10.1016/j.lanepe.2026.101611. eCollection 2026 Mar.
369 participants (actual enrollment reported by the registry).
First Submitted
August 27, 2025
First Posted
September 4, 2025
Study Start
July 21, 2025
Actual (reported)Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment
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Primary Completion
August 4, 2025
Actual (reported)Study Completion
September 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 11, 2025
Record last verified: 2025-09
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.
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Source: ClinicalTrials.gov.
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