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Scientists Re-Examine old data to see which patients benefit from extra antibiotic for staph blood infection

NCT ID NCT07155590

Knowledge-focused Sponsor: Hospital Universitari de Bellvitge Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at data from two previous clinical trials involving 369 patients with Staphylococcus aureus bloodstream infections. Researchers want to see if adding the antibiotic fosfomycin to standard care helps certain patient groups more than others. They will classify patients by infection type and risk level to find who might benefit most. The goal is to improve treatment decisions for this serious infection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fosfomycin
What this could lead to
If successful, this could help doctors identify which patients with staph bloodstream infections are most likely to benefit from adding fosfomycin to standard treatment.
What could go wrong
This is a post-hoc analysis, not a new trial, so results are less reliable. The original trials did not show consistent benefit, and the analysis may not have enough power to confirm findings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

369 people

The number who actually took part.

Started

Jul 2025

Expected to finish

Sep 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

staphylococcus aureus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Staphylococcal aureus infection Staphylococcus aureus bacteraemia

Contacts and locations

Locations

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Catalonia, 08907, Spain

  • Hospital Universitario Virgen de Macarena

    Seville, 41009, Spain

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