Combination Antibiotic Treatment With Linezolid for Staphylococcus Aureus Bacteraemia: a Randomised Controlled Trial
Led by University Hospital, Basel, Switzerland · Updated on 2026-03-24
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Brief Title
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Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
S
Swiss National Science Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Staphylococcus aureus bloodstream infections (bacteraemia) are serious and deadly bacterial infections that affect many people each year, with high rates of death and complications despite existing antibiotic treatments. The study aims to find out if adding linezolid, an antibiotic that may reduce harmful bacterial toxins, to standard antibiotic therapy can improve outcomes for patients with these infections. This trial is a randomized, placebo-controlled study designed to test this approach.
Participants will be randomly assigned to receive either linezolid tablets at a dose of 600 mg twice daily for 5 days along with their usual antibiotic treatment or placebo tablets given on the same schedule with standard care. This study period lasts for 5 days of additional treatment. The trial compares these two groups to evaluate the impact of linezolid added to standard treatment on infection outcomes.
During the study, participants will be closely monitored from the first day of randomization until 90 days later. Researchers will assess a variety of outcomes including overall health status, mortality, infection clearance, hospital stay length, antibiotic use, mental and physical health, and any side effects or adverse reactions. These evaluations include clinical exams, laboratory tests, and monitoring for complications or new antibiotic resistance. Safety and effectiveness data will be collected throughout the follow-up period to understand how well the treatment works and its impact on patients' recovery.
CONDITIONS
Brief Title
Linezolid Plus Standard of Care
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Staphylococcus aureus grown from at least one blood culture
Hospitalised at a participating centre
18 years old or older
Written informed consent or meets emergency exception criteria for consent
You will not qualify if you...
Cannot start study drug within 72 hours of first positive blood culture
Positive blood cultures for Staphylococcus aureus between 72 hours and 180 days before screening
Necrotising fasciitis
Currently receiving linezolid or clindamycin
Use of any monoamine oxidase inhibitor within the last two weeks
Known allergy to linezolid or study drug ingredients
Severe low platelet count (less than 30 x 10^9/L)
Unable to take study drug by mouth or feeding tube
Currently breastfeeding
Expected death is imminent and inevitable
Receiving end of life care with no antibiotic treatment planned
Participation not considered in patient's best interest by treating team
Patient unwilling to participate or has an advance directive against participation
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 5 days
Participants receive either linezolid 600 mg tablets or placebo tablets twice a day for 5 days, in addition to standard antibiotic therapy for Staphylococcus aureus bacteraemia.
Daily visits or assessments during the 5-day treatment period
Follow-up
Duration - Up to 90 days
Participants are monitored for clinical outcomes, adverse events, and recovery for up to 90 days after randomization.
Multiple follow-up visits or assessments during 90-day post-treatment period
Linezolid in addition to standard antibiotic treatment for Staphylococcus aureus bacteraemia: study protocol for a randomised, placebo-controlled trial.
Natalie Rose, Nadine S Bernasconi, Michaela Schumacher...