Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-27 @ 10:19 PM
Study NCT ID:
NCT06081361
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-01
First Post:
2023-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort
Sponsor:
Beijing Chest Hospital
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Open-Label Study To Evaluate The Efficacy And Safety Of A Contezolid, Delamanid and Bedaquiline-Containing Short Regimen For The Treatment Of Rifampicin-Resistant Pulmonary Tuberculosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
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:
INSPIRE-CODA
Brief Summary:
The goal of this clinical trial is to compare the efficacy and safety of a Contezolid and Delamanid-Containing short regimen to standard longer regimen in Rifampicin-resistant pulmonary tuberculosis (RR-TB). The main questions it aims to answer are:
* Is the efficacy of short regimen non-inferior to standard regimen?
* Is the short regimen safe enough to replace the standard regimen?
Participants will:
* Be given with either short or standard regimen for RR-TB treatment
* Be asked to complete the scheduled visit as planned.
* Is the efficacy of short regimen non-inferior to standard regimen?
* Is the short regimen safe enough to replace the standard regimen?
Participants will:
* Be given with either short or standard regimen for RR-TB treatment
* Be asked to complete the scheduled visit as planned.
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?: