Adult Patients Developing Optic or Peripheral NeuropathyNCT07143240
Tedizolid Neuropathies
An observational study of Adult Patients Developing Optic or Peripheral Neuropathy and While Receiving Tedizolid Therapy Between July 2019 and December 2024, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adult Patients Developing Optic or Peripheral Neuropathy, While Receiving Tedizolid Therapy Between July 2019 and December 2024
- What is being tested?
- Determine patient demographic and clinical characteristics at baseline
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2025to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Adult patients developing optic or peripheral neuropathy while receiving tedizolid treatment.
Who may be able to join
- 18 years
- Patients developing optic or peripheral neuropathy while receiving tedizolid therapy
Who cannot join
- 18 years
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Determine patient demographic and clinical characteristics at baseline
- Keywords
- Infectiology, tedizolid
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determine patient demographic and clinical characteristics at baselineOther
Description of demographic data (sex, age), comorbidities (Charlson scores), septic history, clinical data relating to neuropathy, and tedizolid prescription modalities (dose, duration).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Determine patient demographic and clinical characteristics at baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Mar 2025
- Primary completion1 Apr 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients Developing Optic or Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143240
- Sponsor's protocol ID
- 25-5138
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tedizolid Neuropathies
- ClinicalTrials.gov ID
- NCT07143240
- Acronym / sponsor ID
- 25-5138
- Conditions
- Adult Patients Developing Optic or Peripheral Neuropathy, While Receiving Tedizolid Therapy Between July 2019 and December 2024
- Keywords
- Infectiology, tedizolid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients developing optic or peripheral neuropathy while receiving tedizolid therapy | – | Other: Determine patient demographic and clinical characteristics at baselineThe 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients developing optic or peripheral neuropathy while receiving tedizolid treatment.
Key inclusion criteria (2 listed)
- 18 years
- Patients developing optic or peripheral neuropathy while receiving tedizolid therapy
Key exclusion criteria (1 listed)
- 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determine patient demographic and clinical characteristics at baselineDescription of demographic data (sex, age), comorbidities (Charlson scores), septic history, clinical data relating to neuropathy, and tedizolid prescription modalities (dose, duration). | Other | Adult patients developing optic or peripheral neuropathy while receiving tedizolid therapy |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Patients Developing Optic or Peripheral Neuropathy and While Receiving Tedizolid Therapy Between July 2019 and December 2024, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.