Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568484
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB BREACH-TB
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
BREACH-TB
Brief Summary:
A Phase III open-label multicenter non-inferiority trial to compare the efficacy and safety of 4 weeks of bedaquiline BDQ versus a World Health Organization WHO -recommended regimen for preventing confirmed or probable tuberculosis disease TBD during 96 weeks of follow-up among people living with HIV PLHIV and high-risk Close Contacts CC of adults with Drug Susceptible DS or Rifampin Resistant RR TB
Detailed Description:
Treating adult adolescent child and pregnant close contacts CCs of drug-sensitive tuberculosis DS-TB who are high-risk for developing tuberculosis disease TBD as well as adult and adolescent people living with HIV PLHIV in high-tuberculosis burden regions with bedaquiline BDQ will be noninferior in reducing the risk of developing TBD compared with a WHO-recommended rifamycin-containing short-course regimen for TB preventive therapy TPT
Treating adult adolescent child and pregnant CCs of rifampin-resistant tuberculosis RR-TB who are high-risk for developing TBD with BDQ will be noninferior in reducing the risk of developing TBD compared with levofloxacin
Treating adult adolescent child and pregnant CCs of rifampin-resistant tuberculosis RR-TB who are high-risk for developing TBD with BDQ will be noninferior in reducing the risk of developing TBD compared with levofloxacin
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