Trial · NCT06958835
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Desirability of Outcome Ranking (DOOR) | From randomisation (day 1) until day 90 | 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. |
| Secondary | All-cause mortality | From randomisation (day 1) until day 90 | Proportion of patients who died from any cause during the duration of the study. |
| Secondary | Time to death | From randomisation (day 1) until day 90 | |
| Secondary | Level of function | From randomisation (day 1) until day 90 | Proportion of participants back to their usual level of function prior to the infection. |
| Secondary | Number of participants with microbiological failure leading to treatment change | From day 14 to day 90 (randomisation = day 1) | 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. |
| Secondary | Number of participants with early microbiological failure leading to treatment change | From day 5 to day 13 (randomisation = day 1) | Any positive sterile site culture with S. aureus between 5 and 13 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. |
| Secondary | Number of participants with clinical failure leading to treatment change | From day 14 to day 90 (randomisation = day 1) | Newly identified focus of S. aureus between 14 and 90 days after randomisation as determined by the site investigator (or delegated physician) that leads to a change in treatment. This can incorporate clinical, radiological, microbiological and pathological findings. |
| Secondary | Number of participants with early clinical failure leading to treatment change | From day 5 to day 13 (randomisation = day 1) | Newly identified focus of S. aureus between 5 and 13 days after randomisation as determined by the site investigator (or delegated physician) that leads to a change in treatment. This can incorporate clinical, radiological, microbiological and pathological findings. |
| Secondary | Hospital length of stay | From randomisation (day 1) until day 90 | Duration of the index acute hospital stay from randomisation until the day of hospital discharge. Transfers to another acute care hospital for continuation of acute treatment will be included in the assessment of hospital length of stay. Days after transfer to rehabilitation centres or switch to outpatient parenteral ambulatory treatment will not be included in the acute hospital stay. |
| Secondary | Time to being discharged alive | From randomisation (day 1) until day 90 | For participants who die during the hospitalisation, 90 days will be recorded. |
| Secondary | Days alive without being on the Intensive Care Unit (ICU) | From randomisation (day 1) until day 90 | Number of days a participant is alive and not hospitalised in the Intensive Care Unit. |
| Secondary | Days alive without antibiotics | From randomisation (day 1) until day 90 | Number of days a participant is alive and not on any antibiotics. |
| Secondary | Mental health | At day 90 (randomisation = day 1) | Mental health assessed by patient-reported outcome using Short Form-36 (SF-36) questionnaire. The SF-36 questionnaire score ranges from 0 to 100, with higher scores indicating better health. |
| Secondary | Physical health | At day 90 (randomisation = day 1) | Physical health assessed by patient-reported outcome using SF-36 questionnaire. The SF-36 questionnaire score ranges from 0 to 100, with higher scores indicating better health. |
| Secondary | Number of participants with persistent bacteraemia | At day 5 (randomisation = day 1) | S. aureus-positive blood culture on day 5 (±1 day) after randomisation. If day 2 or day 3 blood cultures are negative and no subsequent blood cultures are performed, the day 5 blood culture is presumed to be negative. |
| Secondary | Two or more systemic inflammatory response syndrome (SIRS) criteria fulfilled | At day 5 (randomisation = day 1) | SIRS criteria: * Abnormal body temperature (\<36°C or \>38°C) * tachypnoea or mechanical ventilation (RR\>20 breaths per minute) * tachycardia (HR \>90 beats per minute in an adult * abnormal leukocyte count (from routine blood sampling on day 5 ±1 day, defined as \>12.0 x 10\^9/L or \<4.0 x 10\^9/L or \>10% of immature (band) forms) |
| Secondary | Change in C-reactive protein (CRP) | From randomisation (day 1) until day 5 | Day 1 CRP means any blood CRP measurement taken on randomisation day 1 or the calendar day prior to randomisation. If there is more than one measurement, the value recorded is the one taken closest before randomisation. |
| Secondary | Development of new antibiotic drug resistance in Staphylococcus aureus | From randomisation (day 1) until day 90 | Any new resistance absent in the S. aureus from the initial blood culture and detected in any S. aureus cultured after the start of the intervention. |
| Secondary | Adverse events leading to study drug discontinuation | From randomisation (day 1) until day 5 | Any adverse event (irrespective of grade) leading to study drug discontinuation as documented by the treating physician. |
| Secondary | Serious adverse reactions until day 90 | From randomisation (day 1) until day 90 | Any serious adverse event will be reported to the study-site principal investigator, who then assesses whether there is a reasonable causal relationship with the investigational medicinal product. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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