Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB)

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Sep 6, 2022

Keywords

ClinConnect Summary

The TEDITUB clinical trial is studying two medications, tedizolid and linezolid, to see how effective they are in killing the bacteria that cause tuberculosis (TB), particularly in cases where the TB is resistant to multiple drugs. The goal is to measure how quickly these medications can reduce the bacteria in patients with pulmonary (lung) TB. This trial is currently looking for participants who are between 18 and 75 years old and have a confirmed first infection of TB in their lungs. Women who can become pregnant and men must use effective contraception during the study.

If you join this trial, you will receive either tedizolid, linezolid, or standard TB treatment, and doctors will closely monitor your health throughout the study. It’s important to know that not everyone with TB will qualify; for example, those with a history of TB treatment or certain medical conditions may be excluded. Participants will need to sign a consent form to ensure they understand the study and its requirements. This trial aims to improve treatment options for TB, especially for those with drug-resistant forms of the disease.

Gender

ALL

Eligibility 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