Condition: Tuberculosis, Pulmonary · Tuberculosis, Multidrug-Resistant · Tuberculosis, MDR · Sponsor: University of California, San Francisco
PRISM-TB is an international, seamless, multicenter, open-label, randomized, controlled, pragmatic, stratified medicine, treatment shortening, multi-arm multi-stage (MAMS), noninferiority Phase 2/3 clinical trial for fluoroquinolone-susceptible multidrug-resistant/rifampin-resistant pulmonary tuberculosis (FQ-S MDR/RR-TB). In Stage 1, participants will be randomized among one of three treatment arms (one control and two experimental). Following the interim analysis (at the end of Stage 1) based on DOOR outcome comparisons and the entirety of the data, one of the four possible experimental strategies will be identified and continue into Stage 2. In Stage 2, participants will be randomized among one of two treatment arms (one control and one experimental). The trial objective is to identify, among participants with fluoroquinolone-susceptible multidrug-resistant/rifampicin-resistant tuberculosis (FQ-S MDR/RR-TB), the preferred BPaLM strategy of 13 or 17 weeks for participants stratified to receive shorter treatment and 17 or 24 weeks for participants stratified to receive longer treatment, as defined by a prespecified stratification algorithm, and to evaluate whether this BPaLM strategy has noninferior efficacy to the control strategy at Week 73.
This description comes directly from the study's public registry record.
Gustavo E Velásquez, MD, MPH · (628) 206-2400 · gustavo.velasquez@ucsf.edu
Ariana F Austin, MS · prism.central@ucsf.edu
Always discuss trial participation with your own doctor first.
| National Center for Communicable Diseases | Ulaanbaatar, Mongolia | Recruiting |
| Institute of Chest Diseases | Kotri, Pakistan | Not Yet Recruiting |
| Hospital Nacional Sergio E. Bernales | Lima, Peru | Not Yet Recruiting |
| Policlínico SES | Lima, Peru | Recruiting |
| Mulago National Referral Hospital | Kampala, Uganda | Recruiting |
| Hanoi Lung Hospital | Hanoi, Vietnam | Not Yet Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06441006