Tedizolid Neuropathies

Completed

• Conditions: Adult Patients Developing Optic or Peripheral Neuropathy; While Receiving Tedizolid Therapy Between July 2019 and December 2024

• Registration Number: NCT07143240
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Tedizolid is a new oxazolidinone, related to linezolid. It has obtained marketing authorization for the treatment of skin and soft tissue infections. Its potential interest compared to linezolid lies mainly in its better tolerance in the context of more prolonged treatments required in chronic Gram-positive cocci infections such as osteoarticular infections. Indeed, linezolid has hematological toxicity, appearing beyond 10 days of treatment. Due to a lower dosage and lower mitochondrial toxicity, the hematological tolerance of tedizolid is better, even allowing it to be used as a relay from linezolid after the occurrence of hematotoxicity. Another side effect of the oxazolidinone class is the occurrence of optic and peripheral neuropathies observed under linezolid. The pharmacological properties of tedizolid and in vitro and in vivo data suggested a lower risk of neurotoxicity, although a few cases have been published..

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-01
• Primary Completion: 2025-04-01
• Study Completion: 2025-05-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-08
• Study First Submitted QC: 2025-08-19
• Last Update Submitted: 2025-08-19
• Study First Posted: 2025-08-27
• Last Update Posted: 2025-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• 18 years
• Patients developing optic or peripheral neuropathy while receiving tedizolid therapy

Exclusion Criteria

• 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Describe cases of tedizolid-induced neurotoxicity.	The outcome will be measured at the last follow-up visit in 2024, i.e. a maximum of 4 years after the start of the neuropathy.	Retrospective cohort describing neurological side effects occurring under tedizolid. Patients will be identified by cross-referencing data from medical records of the infectious diseases department of the Lyon University Hospital, the prospective database of CRIOAc Lyon recording the side effects of new molecules (including tedizolid), and pharmacovigilance data. Description of patient history and clinical data, and tedizolid prescription methods (dose, duration).; Unit of Measure :Number of patients (n)

Trial Locations

Locations (1)

HCL; 🇫🇷 Lyon, France, France