Tests tedizolid against tuberculosis compared with linezolid and standard therapy
Tests tedizolid's early effect on tuberculosis bacteria in adults with lung infection.
Plain-language title generated from the registry record
Registry title: Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB)
Key facts
- Where
- Argenteuil Cedex, Bobigny, Boulogne-Billancourt, Garches, Jossigny, Paris, Paris Cedex 10, Paris Cedex 12, Paris Cedex 18, Paris Cedex 20, and St Denis Cedex, FranceSee the 13 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05534750, who can take part
Where in France
- Centre Hospitalier Victor DupouyArgenteuil Cedex, FranceTaking people
- Assistance Publique Hopitaux De ParisBobigny, FranceTaking people
- Hôpital Ambroise-ParéBoulogne-Billancourt, FranceTaking people
- Assistance Publique Hopitaux De ParisGarches, FranceTaking people
- Grand Hopital De L Est FrancilienJossigny, FranceTaking people
- Assistance Publique Hopitaux de ParisParis, FranceTaking people
- Hopital Necker Enfants MaladesParis, FranceTaking people
- Hopitaux Universitaires Pitie SalpetriereParis, FranceTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 10, FranceTaking people
- Hopital Saint AntoineParis Cedex 12, FranceTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 18, FranceTaking people
- Hopital TenonParis Cedex 20, FranceTaking people
- Centre Hospitalier General De St DenisSt Denis Cedex, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT05534750EU 2024-512759-19-00
- Record updated
- 3 February 2025
- Original description
The objective of this work is to measure the early bactericidal activity of tedizolid, to compare it with the bactericidal activity of linezolid (reference molecule for the treatment of multidrug-resistant tuberculosis) and with that of standard quadruple therapy (reference treatment of drug susceptible tuberculosis).Read full original descriptionShow less
Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis
The objective of this work is to measure the early bactericidal activity of tedizolid, to compare it with the bactericidal activity of linezolid (reference molecule for the treatment of multidrug-resistant tuberculosis) and with that of standard quadruple therapy (reference treatment of drug susceptible tuberculosis).
Inclusion: 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: History of treatment in the previous two years with one of the antibiotics evaluated in this trial lasting more than one month; 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; 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; 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); 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); Absolute contraindication to the use of at least one of the test molecules (isoniazid, rifampicin, ethambutol, pyrazinamide, linezolid, tedizolid); 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; Hyperuricaemia; Porphyria; Optic neuritis or peripheral neuropathy; BMI≤ 16 kg/m2; Participation in other interventional research; Gastrointestinal topicals, antacids and adsorbents and salts and aluminum hydroxides.