NCT05534750

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This is a Phase 2, prospective, randomized, open-label controlled trial in 3 parallel groups comparing tedizolid with 2 standard treatments: linezolid (oxazolidinone whose anti-tuberculosis activity has already been demonstrated) and standard treatment for tuberculosis (quadruple therapy: isoniazid, rifampicin, ethambutol, pyrazinamide ). The objective is to measure the early bactericidal activity of tedizolid, to compare it with the bactericidal activity of linezolid and with that of standard quadruple therapy. Design: A multicentric, open-label, randomized clinical trial Sample size : 60 patients, 20 in each group Treatments groups: * Tedizolid arm: * Tedizolid (SIVEXTRO®), * 200 mg film-coated tablet * Dosage of 1 tablet per day to be taken in the morning for 7 days (taken with or without meals). * Linezolid arm (ZYVOXID®): * Linezolid arm (ZYVOXID®) * 600 mg film-coated tablet * Dosage of 2 tablets per day to be taken in the morning for 7 days (taken with or without meals). * Standard quadruple therapy arm: * Isoniazid (RIMIFON®) Tablets 50 or 200 mg Dosage 3 to 5mg / kg / day for 7 days to be taken in the morning on an empty stomach. * Rifampicin, dosage 10mg / kg / day for 7 days to be taken in the morning on an empty stomach. * Ethambutol 15-20mg / kg / day for 7 days to be taken in the morning on an empty stomach. * Pyrazinamide 20-25mg / kg / day for 7 days to be taken in the morning on an empty stomach. Treatment duration : 7 days Assessement: After signing the consent, patients will be randomized, a sputum sample will be taken before the first drug intake. Then, patients will be treated for 7 days depending on the randomization group (tedizolid, linezolid or standard quadruple therapy). Daily, a sputum of at least 2 mL will be withdrawn from the patients for 7 days. A consultation with blood test will be carried out on D30, date of the patient's end of participation. No interim analysis is planned. Analysis will be performed at the end of the study after data review and freezing of database.

Conditions

• Tuberculosis
• Multidrug Resistant Tuberculosis

Interventions

Type	Name	Description
DRUG	Tedizolid arm (SIVEXTRO®)	Patients will be taken 1 tablet per day of 200 mg film-coated of Tedizolid (SIVEXTRO®), in the morning for 7 days. Then, the early bactericidal activity will be measured and compared to the other arms.
DRUG	Linezolid arm (ZYVOXID®)	Patients will be taken 2 tablets per day of 600 mg film-coated of Linezolid (ZYVOXID®) in the morning for 7 days. Then, the early bactericidal activity will be measured and compared to the other arms.
DRUG	Standard quadruple therapy arm	Patients will be taken : ISONIAZIDE : o A dosage of 5mg / kg / day for 7 days (to be taken in the morning on an empty stomach) of Isoniazid (RIMIFON®) RIFAMPICINE : o A dosage of 10mg / kg / day for 7 days (to be taken in the morning on an empty stomach) ETHAMBUTOL : o A dosage of 15-20mg / kg / day for 7 days (to be taken in the morning on an empty stomach) of Ethambutol PYRAZAMIDE : o A dosage of 20-25mg / kg / day for 7 days (to be taken in the morning on an empty stomach) of Pyrazinamide Then, the early bactericidal activity will be measured and compared to the other arms.

Timeline

• Start date: 2023-04-20
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2022-09-09
• Last updated: 2025-02-03

Locations

1 site across 1 country: France