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

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 20, 2023

Primary Completion Date

April 30, 2026

Study Completion Date

May 31, 2026

Conditions
TuberculosisMultidrug Resistant Tuberculosis
Interventions
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."

Trial Locations (1)

75012

RECRUITING

Bacteriology department- Hôpital Saint-Antoine, Paris

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER