Linezolid added to standard care for Staphylococcus aureus bloodstream infection
Combination Antibiotic Treatment With Linezolid for Staphylococcus Aureus Bacteraemia: a Randomised Controlled Trial
This trial will test whether giving linezolid in addition to usual antibiotics helps adults hospitalized with Staphylococcus aureus bloodstream infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 606 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 12 sites (Aarau, Canton of Aargau and 11 other locations) |
| Trial ID | NCT06958835 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) hospitalized at a participating Swiss center with a recent positive blood culture for Staphylococcus aureus who can start treatment within 72 hours and are not already on linezolid or contraindicated medications.
Not a fit: Patients with necrotising fasciitis, recent prior S. aureus bacteraemia, current linezolid or clindamycin therapy, severe thrombocytopenia, inability to take the drug enterally, or those breastfeeding are unlikely to be eligible and may not receive benefit from this approach.
Why it matters
Potential benefit: If successful, adding linezolid could lower death and complication rates by reducing bacterial toxin production alongside standard antibiotics.
How similar studies have performed: Preclinical animal studies and observational human data suggest linezolid reduces S. aureus toxin production and may improve outcomes, but no randomized controlled trial has yet proven this in bloodstream infections.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aarau, Canton of Aargau and 11 other locations
- Kantonsspital Aarau (KSA) — Aarau, Canton of Aargau, Switzerland (Recruiting)
- St. Claraspital — Basel, Canton of Basel-City, Switzerland (Recruiting)
- Hôpitaux universitaires de Genève (HUG) — Geneva, Canton of Geneva, Switzerland (Not_yet_recruiting)
- Hôpital du Jura — Delémont, Canton of Jura, Switzerland (Not_yet_recruiting)
- Centre hospitalier universitaire vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland (Not_yet_recruiting)
- Kantonsspital Winterthur (KSW) — Winterthur, Canton of Zurich, Switzerland (Not_yet_recruiting)
- Ente Ospedaliero Cantonale (EOC) — Lugano, Canton Ticino, Switzerland (Recruiting)
- University Hospital Basel (USB) — Basel, Switzerland (Recruiting)
- Inselspital Bern — Bern, Switzerland (Not_yet_recruiting)
- HOCH Health Ostschweiz, Kantonsspital St.Gallen — Sankt Gallen, Switzerland (Not_yet_recruiting)
- Stadtspital Zürich Triemli — Zurich, Switzerland (Recruiting)
- Universitätsspital Zürich (USZ) — Zurich, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.