RecruitingNot ApplicableNCT06958835
Linezolid Plus Standard of Care
Combination Antibiotic Treatment With Linezolid for Staphylococcus Aureus Bacteraemia: a Randomised Controlled Trial
Sponsor
University Hospital, Basel, Switzerland
Enrollment
606 participants
Start Date
Oct 6, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The aim of the study is to assess whether targeting virulence factors by administering linezolid in addition to standard antibiotic treatment improves outcomes in patients with Staphylococcus aureus bacteraemia.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- Staphylococcus aureus (S. aureus) grown from at least one blood culture
- Hospitalised at a participating centre
- ≥18 years old
- Written informed consent or fulfilling criteria for an emergency exception from informed consent requirements
Exclusion Criteria13
- Administration of the initial drug treatment not feasible within 72 hours since the collection of the first positive blood culture with S. aureus
- Documented history of positive blood cultures for S. aureus occurring between 72 hours and 180 days prior to the eligibility assessment
- Necrotising fasciitis
- Currently receiving linezolid or clindamycin
- Use of any monoamine oxidase A or B inhibitor within the last two weeks
- Known hypersensitivity to linezolid or any other ingredients of the study drugs
- Current severe thrombocytopenia (i.e. \<30 x 10\^9/L)
- Application of study drug not possible (per mouth or per gastric tube)
- Currently breastfeeding
- Local treating team believes that death is imminent and inevitable
- Patient is receiving end of life care and antibiotic treatment is not considered appropriate
- Local treating team believes that participation in the study is not in the best interest of the patient
- Any indication that the patient is unwilling to participate in the study including an advance directive stating such unwillingness
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Interventions
DRUGLinezolid 600 mg
linezolid 600 mg tablets (twice a day for 5 days)
DRUGPlacebo
Placebo tablets (twice a day for 5 days)
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06958835