Linezolid Plus Standard of Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Linezolid 600 mg, Placebo.
- Who it may be relevant to
- Registry conditions: Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Combination Antibiotic Treatment With Linezolid for Staphylococcus Aureus Bacteraemia: a Randomised Controlled Trial
Overview
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.
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. Despite widely available antibiotic treatments, the 90-day mortality rate remains high at 20-30%, and complications such as organ damage, relapses, and long-term impairment affect many survivors. Existing treatments have failed to improve survival rates highlighting the urgent need for novel therapeutic strategies.
Virulence factors produced by S. aureus facilitate bacterial persistence and spread, and tissue damage. Preclinical research suggests that inhibiting the production of virulence factors may improve patient outcomes. While some clinical guidelines recommend this approach for toxin-mediated infections, randomized controlled trials (RCTs) evaluating this approach in S. aureus bacteraemia have not yet been conducted.
Linezolid, an antibiotic commonly used for pneumonia and complicated skin and soft-tissue infections, has shown strong inhibition of the expression of S. aureus virulence factors in preclinical studies. Studies in animal models demonstrated that linezolid, when combined with other antibiotics, enhances treatment efficacy and reduces bacterial toxin production. Observational studies suggest that early initiation of linezolid may lead to better patient outcomes, but no RCT has tested this approach in S. aureus bacteraemia.
This placebo-controlled trial will evaluate whether adding a 5-day course of linezolid to standard antibiotic therapy improves clinical outcomes in patients with S. aureus bacteraemia.
Interventions
- Drug Linezolid 600 mg
linezolid 600 mg tablets (twice a day for 5 days) - Drug Placebo
Placebo tablets (twice a day for 5 days)
Primary outcome measures
- Desirability of Outcome Ranking (DOOR) [Time frame: From randomisation (day 1) until day 90]
Secondary outcome measures (12)
- All-cause mortality [Time frame: From randomisation (day 1) until day 90]
- Time to death [Time frame: From randomisation (day 1) until day 90]
- Level of function [Time frame: From randomisation (day 1) until day 90]
- Number of participants with microbiological failure leading to treatment change [Time frame: From day 14 to day 90 (randomisation = day 1)]
- Number of participants with early microbiological failure leading to treatment change [Time frame: From day 5 to day 13 (randomisation = day 1)]
- Number of participants with clinical failure leading to treatment change [Time frame: From day 14 to day 90 (randomisation = day 1)]
- Number of participants with early clinical failure leading to treatment change [Time frame: From day 5 to day 13 (randomisation = day 1)]
- Hospital length of stay [Time frame: From randomisation (day 1) until day 90]
- Time to being discharged alive [Time frame: From randomisation (day 1) until day 90]
- Days alive without being on the Intensive Care Unit (ICU) [Time frame: From randomisation (day 1) until day 90]
- Days alive without antibiotics [Time frame: From randomisation (day 1) until day 90]
- Mental health [Time frame: At day 90 (randomisation = day 1)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Switzerland · 12 centers
- Kantonsspital Aarau (KSA) — Aarau
- St. Claraspital — Basel
- Inselspital Bern — Bern
- Hôpitaux universitaires de Genève (HUG) — Geneva
- Hôpital du Jura — Delémont
- HOCH Health Ostschweiz, Kantonsspital St.Gallen — Sankt Gallen
- Centre hospitalier universitaire vaudois (CHUV) — Lausanne
- Kantonsspital Winterthur (KSW) — Winterthur
- … and 4 more centers
Publications
- Rose N, Bernasconi NS, Schumacher M, Werlen L, Buchel D, Weisser M, Vogt SB, Wehrle-Wieland E, Conen A, Thurnheer MC, Martin Y, Birrer M, Bongiovanni M, Albrich WC, Karrer U, Schibli A, Harbarth S, Papadimitriou-Olivgeris M, Briel M, Hasse B, Khanna N, Kuehl R, Speich B. Linezolid in addition to standard antibiotic treatment for Staphylococcus aureus bacteraemia: study protocol for a randomised, p PMID 42009378
Identifiers
NCT: NCT06958835 · 2025-00655; am23Khanna3