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OpenTrials
Completed

NCT Number: NCT07143240

Tedizolid Neuropathies

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..

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 18 years

Treatment and study plan

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).

Primary outcomes

  1. Describe cases of tedizolid-induced neurotoxicity.

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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