Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 75

Comparing the effectiveness of tedizolid and linezolid for treating tuberculosis

Official title: Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis

Run by Assistance Publique - Hôpitaux de Paris · NCT05534750 · Data updated 2026-11-12

This study is testing if a new drug called tedizolid can work better than an existing drug, linezolid, in helping people with tuberculosis feel better by reducing the bacteria in their lungs.

More Tuberculosis trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment60 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations1 site (Paris)
StatusRecruiting
StartedApril 20, 2023
Main results expectedApril 2026
Study endsMay 2026
Registry record updatedFebruary 3, 2025
Trial IDNCT05534750 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 75 with a first infection of pulmonary tuberculosis confirmed by positive sputum tests and no resistance to rifampicin.

Probably not a fit

Patients with known resistance to the treatment drugs or those with extra-thoracic tuberculosis may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 clinical trial evaluates the early bactericidal activity of tedizolid compared to linezolid and standard quadruple therapy for tuberculosis. It is a multicentric, open-label, randomized controlled trial involving 60 patients divided into three treatment groups. Each group will receive either tedizolid, linezolid, or standard quadruple therapy for a duration of 7 days. The primary goal is to assess the effectiveness of tedizolid in reducing the bacterial load of Mycobacterium tuberculosis in patients with pulmonary tuberculosis.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with multidrug-resistant tuberculosis.

How similar studies have gone: Other studies have shown promising results with similar approaches, particularly with linezolid, but the use of tedizolid in this context is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age ≥ 18 years old and \<75 years old
* Woman on childbearing age should be on effective contraception during the duration of the study and up to 6 months after treatment; a mechanical contraception (use of condom) will be strongly recommended
* Male (effective contraception must be used during duration of the study and up to 3 months after treatment)
* Patient with a first infection with Mycobacterium tuberculosis of pulmonary localization suspected by the presence of a clinical pulmonary symptomatology, a chest X-ray or an abnormal chest computed tomography, and the positive microscopic examination of a sputum (AFB +, presence of AFB) with confirmation of tuberculosis by a genotypic test demonstrating no resistance to rifampicin, without clinical signs of extra-thoracic involvement
* State medical assistance application being processed ( If patient does not benefit from social security),
* Signature of informed consent

Exclusion Criteria:

* Resistance to one of the anti-tuberculosis drugs used detected by a genotypic test in accordance with the recommendations of the High Council of Public Health of 2015;
* History of anti-tuberculosis treatment (patients with a documented negative genotypic test for isoniazid and rifampicin resistance may be included)
* History of treatment in the previous two years with one of the antibiotics evaluated in this trial lasting more than one month;
* Absolute contraindication to the use of at least one of the test molecules (isoniazid, rifampicin, ethambutol, pyrazinamide, linezolid, tedizolid);
* Tuberculosis having, in the opinion of the investigator, severity criteria not allowing to wait 7 days before starting standard treatment (oxygenorequirement, severe immunosuppression, extra-pulmonary involvement, any sign of severity requiring treatment in intensive care unit);
* HIV-infected patient receiving protease inhibitors whose antiviral treatment cannot be changed and therefore cannot receive rifampicin; or any other drug contraindicated with one of the study treatments (the list of contraindicated drugs is detailed in the following non-inclusion criteria).
* Neoplastic pathology during treatment with chemo and / or radiotherapy;
* Decompensated cirrhosis;
* Pregnancy, desire to become pregnant, breast-feeding (for women of childbearing potential, contraception should be used for the duration of the study and up to 6 months after treatment, mechanical contraception will be strongly recommended and up to 3 months after treatment);
* Protected adults (under guardianship, curatorship) and under safeguard of justice
* Significant laboratory abnormalities (hemoglobin \<9g / dl, polynuclear neutrophils \<500 / mm3, platelets \<50,000 / mm3, creatinine clearance \<30ml / min, ASAT or ALAT\> 3N, and total bilirubin\> 3N)
* Hyperuricaemia
* Porphyria
* Optic neuritis or peripheral neuropathy
* BMI≤ 16 kg/m2
* Participation in other interventional research
* Current treatment with one or more medications contraindicated in combination with linezolid: Linezolid should not be used in patients treated with monoamine oxidase A or B inhibitors (for example: phenelzine, isocarboxacid, selegiline, moclobemide) or who received one of these products in the previous two weeks
* Current treatment with one or more medications contraindicated in combination with quadritherapy:
* Combination with bictegravir, cobicistat, daclatasvir, dasabuvir, delamanid, grazoprevir/elbasvir, protease inhibitors boosted by ritonavir, isavuconazole, ledipasvir, lurasidone, midostaurin, ombitasvir/paritaprevir, praziquantel, rilpivirine, sofosbuvir, velpatasvir, voriconazole, voxilaprevir
* Gastrointestinal topicals, antacids and adsorbents and salts and aluminum hydroxides

Where it's running

  • Bacteriology department- Hôpital Saint-Antoine
    Paris, France
    Recruiting

Study contacts

  • Principal investigator: Nicolas VEZIRIS, PU-PH — Assistance Publique - Hôpitaux de Paris
  • Study coordinator: Nicolas VEZIRIS, PU-PH
  • Email: nicolas.veziris@aphp.fr
  • Phone: 01 49 28 30 41

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.