Linezolid added to standard care for Staphylococcus aureus bloodstream infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled trial gives adults hospitalized with S. aureus bacteraemia either linezolid 600 mg plus standard antibiotics or placebo plus standard antibiotics and follows them for outcomes up to 90 days. The primary outcome uses a hierarchical composite endpoint that captures death, organ dysfunction, relapses, and longer-term impairment. Eligible patients must have at least one positive blood culture for S. aureus and be able to start the study drug within 72 hours, with key exclusions including necrotising fasciitis, recent prior S. aureus bacteremia, current linezolid or clindamycin use, severe thrombocytopenia, and breastfeeding. The trial is run at major Swiss university hospitals with on-site safety monitoring and laboratory support.

Why it matters

Who can join: the full rules

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

Where it's running

• Kantonsspital Aarau (KSA)
  Aarau, Canton of Aargau, Switzerland Recruiting
• St. Claraspital
  Basel, Canton of Basel-City, Switzerland Recruiting
• Inselspital Bern
  Bern, Canton of Bern, Switzerland Recruiting
• Hôpitaux universitaires de Genève (HUG)
  Geneva, Canton of Geneva, Switzerland Recruiting
• Hôpital du Jura
  Delémont, Canton of Jura, Switzerland Recruiting
• HOCH Health Ostschweiz, Kantonsspital St.Gallen
  Sankt Gallen, Canton of St. Gallen, Switzerland Recruiting

Study contacts

• Principal investigator: Richard Kühl, PD Dr. med. — University Hospital, Basel, Switzerland
• Study coordinator: Richard Kühl, PD Dr. med.
• Email: richardalexander.kuehl@usb.ch
• Phone: +41 61 328 66 61

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.