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)

Kantonsspital Aarau (KSA)

Aarau, Canton of Aargau, Switzerland

St. Claraspital

Basel, Canton of Basel-City, Switzerland

Hôpitaux universitaires de Genève (HUG)

Geneva, Canton of Geneva, Switzerland

Hôpital du Jura

Delémont, Canton of Jura, Switzerland

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

Kantonsspital Winterthur (KSW)

Winterthur, Canton of Zurich, Switzerland

Ente Ospedaliero Cantonale (EOC)

Lugano, Canton Ticino, Switzerland

University Hospital Basel (USB)

Basel, Switzerland

Inselspital Bern

Bern, Switzerland

HOCH Health Ostschweiz, Kantonsspital St.Gallen

Sankt Gallen, Switzerland

Stadtspital Zürich Triemli

Zurich, Switzerland

Universitätsspital Zürich (USZ)

Zurich, Switzerland

View Full Details on ClinicalTrials.gov

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NCT06958835


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