Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06958835

Combination Antibiotic Treatment With Linezolid for Staphylococcus Aureus Bacteraemia: a Randomised Controlled Trial

Led by University Hospital, Basel, Switzerland · Updated on 2026-03-24

606

Participants Needed

12

Research Sites

N/A

Total Duration

On this page

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

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

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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

Trial Site Locations

Total: 12 locations

1

Kantonsspital Aarau (KSA)

Aarau, Canton of Aargau, Switzerland

Actively Recruiting

2

St. Claraspital

Basel, Canton of Basel-City, Switzerland

Actively Recruiting

3

Hôpitaux universitaires de Genève (HUG)

Geneva, Canton of Geneva, Switzerland

Not Yet Recruiting

4

Hôpital du Jura

Delémont, Canton of Jura, Switzerland

Not Yet Recruiting

5

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

Not Yet Recruiting

6

Kantonsspital Winterthur (KSW)

Winterthur, Canton of Zurich, Switzerland

Not Yet Recruiting

7

Ente Ospedaliero Cantonale (EOC)

Lugano, Canton Ticino, Switzerland

Actively Recruiting

8

University Hospital Basel (USB)

Basel, Switzerland, 4031

Actively Recruiting

9

Inselspital Bern

Bern, Switzerland

Not Yet Recruiting

10

HOCH Health Ostschweiz, Kantonsspital St.Gallen

Sankt Gallen, Switzerland

Not Yet Recruiting

11

Stadtspital Zürich Triemli

Zurich, Switzerland

Actively Recruiting

12

Universitätsspital Zürich (USZ)

Zurich, Switzerland

Actively Recruiting

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Research Team

R

Richard Kühl, PD Dr. med.

N

Natalie Rose, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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...

https://pubmed.ncbi.nlm.nih.gov/42009378