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.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | April 20, 2023 |
| Main results expected | April 2026 |
| Study ends | May 2026 |
| Registry record updated | February 3, 2025 |
| Trial ID | NCT05534750 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.