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

Phase 1

• Conditions: All infections treated with the antibiotic linezolid; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2020-005772-35-BE
• Lead Sponsor: CLouvain

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-09
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.<br>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 Outcome Measures

Name	Time	Method
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)