Tedizolid Neuropathies

NCT07143240 | Completed

• 1 other identifier: 25-5138
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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..

Conditions

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

Keywords

Infectiology; tedizolid

Outcome Measures

Primary Outcomes (1)

• Describe cases of tedizolid-induced neurotoxicity.

  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)

  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.

Study Arms (1)

Adult patients developing optic or peripheral neuropathy while receiving tedizolid therapy

The study population included subjects aged ≥ 18 years who received tedizolid for infections between July 2019 and December 2024. Subjects younger than 18 years old were excluded.

Other: Determine patient demographic and clinical characteristics at baseline

Interventions

Determine patient demographic and clinical characteristics at baseline OTHER

Description of demographic data (sex, age), comorbidities (Charlson scores), septic history, clinical data relating to neuropathy, and tedizolid prescription modalities (dose, duration).

Adult patients developing optic or peripheral neuropathy while receiving tedizolid therapy

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients developing optic or peripheral neuropathy while receiving tedizolid treatment.

You may qualify if:

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

You may not qualify if:

• years

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

HCL

Lyon, France, 69004, France

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 27, 2025
• Study Start: March 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

FR (1)