Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649721
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Innovating Shorter All- Oral Precised Treatment Regimen for Rifampicin Resistant TuberculosisBDLL Chinese Cohort
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Innovating Shorter All- Oral Precised Treatment Regimen for Rifampicin Resistant TuberculosisBDLL Chinese Cohort
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSPIRE-BDLL
Brief Summary:
This is an investigational prospective multicenter single-arm open label trial The goal of this clinical trial is to evaluate the efficacy and safety of a 6-month all-oral regimen consisting of Bedaquiline BDQ B Delamanid DLM D Linezolid LZD L Levofloxacin LFX or Clofazimine CFZ C or BDLLfxC regimen to treat rifampin-resistant pulmonary tuberculosis RR-TB in Chinese teenagers and adults aged 12 years or above The main questions it aims to answer are
Is BDLLfxC regimen effective to treat RR-TB in Chinese participants
Is BDLLfxC regimen safe in Chinese RR-TB participants Participants will take BDLLfxC regimen to treat their RR-TB There will be no additional hospital visits laboratory tests or radiological examinations other than routine clinical practice
Is BDLLfxC regimen effective to treat RR-TB in Chinese participants
Is BDLLfxC regimen safe in Chinese RR-TB participants Participants will take BDLLfxC regimen to treat their RR-TB There will be no additional hospital visits laboratory tests or radiological examinations other than routine clinical practice
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None