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Linezolid Plus Standard of Care

ConditionStaphylococcus Aureus Bloodstream Infections (BSI; Bacteremia)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Linezolid 600 mg

    Drug

    linezolid 600 mg tablets (twice a day for 5 days)

  • Placebo

    Drug

    Placebo tablets (twice a day for 5 days)

Treatment groups

606 Participants
are divided into 2 treatment groups
Group A: LinezolidExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Desirability of Outcome Ranking (DOOR)

The hierarchical composite endpoint DOOR will be calculated based on the following 4 criteria: 1. Alive at 90 days 2. Return to usual level of function by day 90 3. None of the following complications: Microbiological or clinical failure leading to treatment change; Serious adverse reaction; Adverse event leading to study drug discontinuation 4. Hospital length of stay The primary outcome will be expressed as the win ratio, i.e., the ratio of the number of times that participants in the intervention group have a lower DOOR compared to those in the control group. In this study, a pairwise comparison is used, i.e., every participant in the linezolid group is compared with every participant in the control group. When comparing two participants, the winner will be determined by the first component of the DOOR in which the two participants differ, the only exceptions being ties when both participants die or if they do not die but have the same length of hospitalisation.

Time frame
From randomisation (day 1) until day 90

Secondary outcomes

1

All-cause mortality

Proportion of patients who died from any cause during the duration of the study.

Time frame
From randomisation (day 1) until day 90
2

Time to death

Time frame
From randomisation (day 1) until day 90
3

Level of function

Proportion of participants back to their usual level of function prior to the infection.

Time frame
From randomisation (day 1) until day 90
4

Number of participants with microbiological failure leading to treatment change

Any positive sterile site culture with Staphylococcus aureus (S. aureus) between 14 and 90 days after randomisation that leads to a change in treatment. A sterile site means any site of the body where microorganisms are usually absent, i.e. below the outer and inner colonised surfaces of the skin and mucous membranes. Positive sterile sites cultures include deep visceral and musculoskeletal abscesses obtained in a sterile manner.

Time frame
From day 14 to day 90 (randomisation = day 1)

Other outcomes

1

Linezolid trough plasma concentrations at day 4 or 5

Additional exploratory laboratory outcome for a subset of participants only in participating centres (results may be reported in a publication separate from the publication of the main study results).

Time frame
At day 5 (day of randomisation = day 1)
2

Molecular mechanisms of S. aureus bacteraemia

Basic research on the location of S. aureus in human blood (extracellular or intracellular). This will be conducted in a sub-sample of participants consenting to additional blood sampling and published separately from the publication of the main study results.

Time frame
From randomisation (day 1) until day 90 or until the date of the participant's first blood culture negative for S. aureus, whichever came first.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Basel, Switzerland

Lead sponsor

Swiss National Science Foundation

Collaborator

Source ClinicalTrials.gov
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