Adjunctive Fosfomycin for Treatment of Staphylococcus Aureus Bacteraemia

NCT06695832 | Active Not Recruiting

• 1 other identifier: EOM033/24
• Study Type: observational
• Target: 369
• Locations: 3 countries
• Sites: 6

Brief Summary

Staphylococcus aureus bacteraemia is a frequent and life-threatening infection, despite current standard antibiotic monotherapy. This study aims to clarify the role of fosfomycin as an adjunctive therapy for improving outcomes in patients with this serious infection. Two clinical trials suggested that adjunctive fosfomycin therapy might offer a clinical benefit in certain cases, but the results are inconclusive. We aim to analyse pooled data from these trials in order to identify subgroups of patients that might benefit most from this therapy.

Conditions

Staphylococcus Aureus Bacteremia

Keywords

Staphylococcus aureus bacteremia; Fosfomycin; Daptomycin; Cloxacillin

Outcome Measures

Primary Outcomes (1)

• Treatment success at 8 weeks from the time of randomisation

  A composite outcome available from the information collected in both trials and based on the fulfilment of all the following criteria: * Alive at week 8 from the time of randomisation. * Absence of relapse within 8 weeks after randomisation, defined as isolation of S. aureus in blood cultures after the index blood cultures were cleared. * Improvement of clinical signs and symptoms as assessed by investigators of the BACSARM and SAFO trials at week 8 from the time of randomisation.

  8 weeks from the time of randomisation

Secondary Outcomes (3)

• Persistent bacteraemia

  At days 3 and 7 from the time of randomisation

• Mortality at days 14, 30 and 60 from the time of randomisation

  Days 14, 30 and 60 from the time of randomisation

• Adverse events leading to treatment discontinuation

  During the time that adjunctive fosfomycin therapy was administered

Study Arms (2)

Adjunctive fosfomycin

All patients receiving adjunctive fosfomycin (the combination therapy group).

Standard antibiotic monotherapy group

All patients not receiving fosfomycin, i.e., those receiving daptomycin alone for MRSA bacteraemia or cloxacillin alone for MSSA bacteraemia.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In the BACSARM trial, 155 adult patients with MRSA bacteraemia were randomised 1:1 to receive daptomycin in combination with fosfomycin or daptomycin alone. In the SAFO trial, 214 adult patients with MSSA bacteraemia were randomised 1:1 to receive cloxacillin in combination with fosfomycin or cloxacillin alone. As this is a pooled analysis of all SAB, all patients included in the intention-to-treat analysis of the BACSARM and SAFO trials will be included in the present study, regardless of their susceptibility to methicillin.

You may qualify if:

• All patients included in the BACSARM and SAFO clinical trials.

You may not qualify if:

• For the BACSARM trial: diagnosis of MRSA pneumonia, prior history of eosinophilic pneumonia, use of additional antibiotic therapy with microbiological activity against MRSA.
• For the SAFO trial: prior history of myasthenia gravis, acute SARS-CoV2 infection.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Institut d'Investigació Biomèdica de Bellvitge: collaborator

Study Sites (6)

The Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity

Melbourne, Victoria, 3000, Australia

Location

Institute of Health Policy, Management and Evaluation, University of Toronto

Toronto, Ontario, Canada

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Germans Trias i Pujol Research Institute and Hospital (IGTP)

Badalona, Catalonia, 08916, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08041, Spain

Location

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Study Officials

• Jordi Carratalà, Medical Doctor

  Department of Infectious Diseases, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 19, 2024
• Study Start: November 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: A period of 18 months after publication of the main study results should elapse before requests are made.
• Access Criteria: Researchers who request to BACSAFO principal investigators providing a methodologically reasonable proposal. Interested researchers must obtain the approval of the Bellvitge University Hospital Ethics Committee.

Locations

ES (4); AU (1); CA (1)