Actively Recruiting
Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis
Led by University of California, San Francisco · Updated on 2026-01-20
400
Participants Needed
6
Research Sites
304 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
J
Johns Hopkins University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed fluoroquinolone-susceptible rifampicin-resistant pulmonary tuberculosis by validated testing
- Age 14 years or older
- Verifiable address for home visits and willingness to inform study team of address changes
- Ability and willingness to provide written informed consent or guardian consent and child assent as applicable
- Negative HIV test within 30 days prior to entry or documented HIV infection
- For HIV-positive individuals: CD4+ count of at least 50 cells/mm3 within 30 days prior to entry
- For HIV-positive individuals: currently on or planning to start dolutegravir-based antiretroviral therapy by week 8
- For pregnant individuals: viable singleton pregnancy at 14 weeks gestation or more confirmed by ultrasound
- Chest radiograph obtained within 14 days prior to study entry
You will not qualify if you...
- Allergy, sensitivity, intolerance, or hypersensitivity to study TB drugs or their formulations
- Absolute neutrophil count less than 1000/mm3
- Hemoglobin level below 8.0 g/dL
- ALT or AST levels 3 or more times the upper limit of normal
- Total bilirubin 3 or more times the upper limit of normal
- Creatinine level 3 or more times the upper limit of normal
- Laboratory values indicating potentially life-threatening toxicity (grade 4)
- QTcF interval 480 ms or longer within 5 days prior to entry
- Risk factors for QT prolongation or torsades de pointes including specific heart conditions and family history
- Current grade 2 or higher peripheral neuropathy
- Karnofsky Performance Status Score less than 50 within 14 days prior to entry
- Known resistance to bedaquiline, pretomanid, delamanid, linezolid, or fluoroquinolones
- Prior use of second-line anti-TB drugs for more than 14 days in the past 12 months
- Known or presumed central nervous system, osteoarticular, or disseminated TB in current episode
- Use of contraindicated medications that cannot be stopped or require long washout
- Any condition making participation unsafe or interfering with adherence
- Current enrollment in other therapeutic trials (with exceptions for some prevention trials)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
National Center for Communicable Diseases
Ulaanbaatar, Mongolia
Actively Recruiting
2
Institute of Chest Diseases
Kotri, Pakistan
Not Yet Recruiting
3
Hospital Nacional Sergio E. Bernales
Lima, Peru
Not Yet Recruiting
4
Policlínico SES
Lima, Peru
Not Yet Recruiting
5
Mulago National Referral Hospital
Kampala, Uganda
Not Yet Recruiting
6
Hanoi Lung Hospital
Hanoi, Vietnam
Not Yet Recruiting
Research Team
G
Gustavo E Velásquez, MD, MPH
CONTACT
A
Ariana F Austin, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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