Status:
RECRUITING
Linezolid Plus Standard of Care
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Swiss National Science Foundation
Conditions:
Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 b...
Detailed Description
Staphylococcus aureus (S. aureus) is one of the deadliest bacterial pathogens, especially in high-income countries, and causes bloodstream infections (bacteraemia) in 20-30 per 100,000 people annually...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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 criteria:
- 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
Exclusion
Key Trial Info
Start Date :
October 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
606 Patients enrolled
Trial Details
Trial ID
NCT06958835
Start Date
October 6 2025
End Date
October 1 2028
Last Update
November 17 2025
Active Locations (12)
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1
Kantonsspital Aarau (KSA)
Aarau, Canton of Aargau, Switzerland
2
St. Claraspital
Basel, Canton of Basel-City, Switzerland
3
Hôpitaux universitaires de Genève (HUG)
Geneva, Canton of Geneva, Switzerland
4
Hôpital du Jura
Delémont, Canton of Jura, Switzerland