Etude sur l'usage et les effets secondaires du linezolid en pratique clinique: Suivi de patients traités dans des hôpitaux belges

Study on linezolid use and adverse drug reactions in clinical practice: Follow-up of patients treated in Belgian Hospitals - LINEZOLID

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005772-35-BE

Enrollment

120

Registered

2021-02-09

Start date

2021-04-21

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

All infections treated with the antibiotic linezolid

Interventions

Trade Name: Zyvoxid Product Name: Linezolid Pharmaceutical Form: Coated tablet INN or Proposed INN: Linezolid Other descriptive name: LINEZOLID Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients (> 18 years) Treated with linezolid for a period > 3 days Hospitalizated or non-hospitalizated patients Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Patients with abnormal blood count at the beginning of the treatment (platelets level < 75, 000/mm3 and/or hemoglobin < 8 g/dl)

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess in clinical practice the rate of adverse druf reactions (ADR) in patients treated with linezolid based on data collected by the prescriber and by the patients and using Tools to assess the association between ADR and linezolid (the Naranjo probability scale and WHO-UMC Causality Categories);Secondary Objective: to identify factors associated with the development of adverse reactions and to evaluate the perdormance of 2 predictive scores published for developing hematological toxicity. To assess the importance of linezolid concentration associated with the risk of developing adverse reactions and also measure the linezolid concentration when co-administrated with other drugs. To evaluate the risk of serotonin syndrome in patients co-treated with drugs at risk of developing a serotonin syndrome;Primary end point(s): Number of adverse drug reactions developed during linezolid treatment;Timepoint(s) of evaluation of this end point: 18 months (duration of data collection)	—

Measure

Time frame

Main Objective: To assess in clinical practice the rate of adverse druf reactions (ADR) in patients treated with linezolid based on data collected by the prescriber and by the patients and using Tools to assess the association between ADR and linezolid (the Naranjo probability scale and WHO-UMC Causality Categories);Secondary Objective: to identify factors associated with the development of adverse reactions and to evaluate the perdormance of 2 predictive scores published for developing hematological toxicity. To assess the importance of linezolid concentration associated with the risk of developing adverse reactions and also measure the linezolid concentration when co-administrated with other drugs. To evaluate the risk of serotonin syndrome in patients co-treated with drugs at risk of developing a serotonin syndrome;Primary end point(s): Number of adverse drug reactions developed during linezolid treatment;Timepoint(s) of evaluation of this end point: 18 months (duration of data collection)

—

Secondary

Measure	Time frame
Secondary end point(s): Blood linezolid concentration associated with the development of adverse drug reaction;Timepoint(s) of evaluation of this end point: 18 months (duration of data collection)	—

Countries

Belgium

Contacts

Public ContactGuichet Académique

Clinical Trial Center

guichetacademique-saintluc@uclouvain.be+3227648540

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026