Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-27 @ 6:44 AM
Study NCT ID:
NCT05534750
Status:
RECRUITING
Last Update Posted:
2025-02-03
First Post:
2022-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB)
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEDITUB
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: