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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06695832




Registration number
NCT06695832
Ethics application status
Date submitted
18/11/2024
Date registered
19/11/2024

Titles & IDs
Public title
Adjunctive Fosfomycin for Treatment of Staphylococcus Aureus Bacteraemia
Scientific title
Adjunctive Fosfomycin for Treatment of Staphylococcus Aureus Bacteraemia: Protocol for a Pooled Post-hoc Analysis of Two Randomised Clinical Trials
Secondary ID [1] 0 0
EOM033/24
Universal Trial Number (UTN)
Trial acronym
BACSAFO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Staphylococcus Aureus Bacteremia 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Blood 0 0 0 0
Other blood disorders
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment success at 8 weeks from the time of randomisation
Timepoint [1] 0 0
8 weeks from the time of randomisation
Secondary outcome [1] 0 0
Persistent bacteraemia
Timepoint [1] 0 0
At days 3 and 7 from the time of randomisation
Secondary outcome [2] 0 0
Mortality at days 14, 30 and 60 from the time of randomisation
Timepoint [2] 0 0
Days 14, 30 and 60 from the time of randomisation
Secondary outcome [3] 0 0
Adverse events leading to treatment discontinuation
Timepoint [3] 0 0
During the time that adjunctive fosfomycin therapy was administered

Eligibility
Key inclusion criteria
* All patients included in the BACSARM and SAFO clinical trials.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* For both trials: 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.
* 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.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
Accrual to date
Final
369
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Spain
State/province [2] 0 0
Barcelona
Country [3] 0 0
Spain
State/province [3] 0 0
Catalunya

Funding & Sponsors
Primary sponsor type
Other
Name
Hospital Universitari de Bellvitge
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Institut d'Investigació Biomèdica de Bellvitge
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jordi Carratalà, Medical Doctor
Address 0 0
Department of Infectious Diseases, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual data cannot be shared because of privacy restrictions. Raw anonymised data relating to primary and secondary outcomes and safety can be shared upon request to researchers who provide a methodologically reasonable proposal. The request for data can be sent to the corresponding author (J.C.). A period of 18 months after publication of the main study results should elapse before requests are made, so as to allow authors to publish substudies. Interested researchers must obtain the approval of the Bellvitge University Hospital Ethics Committee.

Supporting document/s available: Study protocol, Clinical study report (CSR)
When will data be available (start and end dates)?
A period of 18 months after publication of the main study results should elapse before requests are made.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06695832