Status:
ACTIVE_NOT_RECRUITING
Subphenotype- and Complication-guided Adjunctive Fosfomycin Therapy for Staphylococcus Aureus Bacteraemia
Lead Sponsor:
Hospital Universitari de Bellvitge
Collaborating Sponsors:
Institut d'Investigació Biomèdica de Bellvitge
University of Barcelona
Conditions:
Staphylococcal Aureus Infection
Staphylococcus Aureus Bacteraemia
Eligibility:
All Genders
18+ years
Brief 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, possi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 21 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 15 2025
Estimated Enrollment :
369 Patients enrolled
Trial Details
Trial ID
NCT07155590
Start Date
July 21 2025
End Date
September 15 2025
Last Update
September 11 2025
Active Locations (2)
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1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Catalonia, Spain, 08907
2
Hospital Universitario Virgen de Macarena
Seville, Spain, 41009