Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441006
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-28
Brief Title:
Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis PRISM-TB
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
PRISM-TB
Brief Summary:
PRISM-TB is an international multicenter open-label randomized controlled pragmatic stratified medicine treatment shortening noninferiority Phase 3 clinical trial for fluoroquinolone-susceptible multidrug-resistantrifampin-resistant pulmonary tuberculosis FQ-S MDRRR-TB
The trial objective is to evaluate whether stratified medicine treatment strategies for FQ-S MDRRR-TB defined by a pre-specified risk stratification algorithm have noninferior efficacy to a one-size-fits-all control regimen the local standard-of-care SOC regimen consistent with preferred regimens in international guidelines as measured by TB-related unfavorable outcomes at Week 73
The trial objective is to evaluate whether stratified medicine treatment strategies for FQ-S MDRRR-TB defined by a pre-specified risk stratification algorithm have noninferior efficacy to a one-size-fits-all control regimen the local standard-of-care SOC regimen consistent with preferred regimens in international guidelines as measured by TB-related unfavorable outcomes at Week 73
Detailed Description:
690 participants will be randomized to the following arms in a 111 randomization
Strategy 1 control strategy Control regimen for all with FQ-S MDRRR-TB The local SOC regimen consistent with preferred regimens in international guidelines In most cases this will be 26 weeks of bedaquiline pretomanid linezolid and moxifloxacin 6BPaLM Doses and durations of each component may change based on the latest WHO guidelines and the local SOC
Strategy 2 investigational strategy 4BPaLM for all with FQ-S MDRRR-TB 17 weeks of bedaquiline pretomanid linezolid and moxifloxacin 4BPaLM
Strategy 3 investigational strategy 3BPaLM or 6BPaLM stratified medicine strategy for those with FQ-S MDRRR-TB
13 weeks of bedaquiline pretomanid linezolid and moxifloxacin 3BPaLM for participants classified as having easier-to-treat TB and 26 weeks of bedaquiline pretomanid linezolid and moxifloxacin 6BPaLM for participants classified as having harder-to-treat TB
Strategy 1 control strategy Control regimen for all with FQ-S MDRRR-TB The local SOC regimen consistent with preferred regimens in international guidelines In most cases this will be 26 weeks of bedaquiline pretomanid linezolid and moxifloxacin 6BPaLM Doses and durations of each component may change based on the latest WHO guidelines and the local SOC
Strategy 2 investigational strategy 4BPaLM for all with FQ-S MDRRR-TB 17 weeks of bedaquiline pretomanid linezolid and moxifloxacin 4BPaLM
Strategy 3 investigational strategy 3BPaLM or 6BPaLM stratified medicine strategy for those with FQ-S MDRRR-TB
13 weeks of bedaquiline pretomanid linezolid and moxifloxacin 3BPaLM for participants classified as having easier-to-treat TB and 26 weeks of bedaquiline pretomanid linezolid and moxifloxacin 6BPaLM for participants classified as having harder-to-treat TB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 7200AA22CA00005 USAID | OTHER_GRANT | USAID | None |