Recruiting

PRISM-TBStratified Medicine for Tuberculosis Treatment with Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin

What is being tested

Bedaquiline

+ Linezolid

+ Pretomanid

Drug

Who is being recruted

Actinomycetales Infections+9

+ Bacterial Infections and Mycoses

+ Bacterial Infections

Over 14 Years

+21 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2 & 3

Interventional

Study Start: October 2025

See protocol details

Summary

Principal SponsorUniversity of California, San Francisco

Study ContactGustavo E Velásquez, MD, MPHMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 3, 2025

Actual date on which the first participant was enrolled.

This clinical study focuses on treating tuberculosis (TB) that is resistant to a specific antibiotic called rifampicin. It aims to find the most effective treatment strategies for people with a certain type of TB known as fluoroquinolone-sensitive multidrug-resistant or rifampicin-resistant tuberculosis (FQ-S MDR/RR-TB). This study is important because it explores different combinations and durations of existing TB medicines, like bedaquiline, pretomanid, linezolid, and moxifloxacin, to see if shorter treatment times can be just as effective as longer ones. Finding a more efficient treatment regimen could significantly improve patient care and outcomes by reducing the treatment burden and potentially lessening side effects. Participants in the study are divided into different groups to receive one of several treatment plans. In the first stage, three different strategies are tested, including a standard 24-week regimen and two shorter investigational regimens lasting 13 or 17 weeks. In the second stage, the best-performing treatment strategy from the first stage is compared with a standard regimen. Participants will receive these treatments orally, and the results will be evaluated based on how well the TB infection is controlled. This study does not specify any particular risks or benefits, but the aim is to identify the most effective and efficient treatment plan for patients with this form of TB.

Official TitleProgram for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis (PRISM-TB)

NCT06441006

Principal SponsorUniversity of California, San Francisco

Study ContactGustavo E Velásquez, MD, MPHMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

400 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 14 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Actinomycetales InfectionsBacterial Infections and MycosesBacterial InfectionsInfectionsLung DiseasesMycobacterium InfectionsRespiratory Tract DiseasesRespiratory Tract InfectionsTuberculosisTuberculosis, PulmonaryGram-Positive Bacterial InfectionsTuberculosis, Multidrug-Resistant

Criteria

9 inclusion criteria required to participate

Documentation of negative HIV infection status within 30 days prior to study entry or documentation confirming HIV infection at any time before study entry.

Chest radiograph obtained within 14 days prior to study entry.

Confirmed fluoroquinolone-susceptible rifampicin-resistant pulmonary tuberculosis, based on sputum Xpert MTB/RIF and Xpert MTB/XDR, and/or other validated molecular test, and/or phenotypic drug susceptibility testing.

For individuals who are pregnant: at screening, evidence by ultrasound of a viable singleton pregnancy with an estimated gestational age at enrollment of ≥ 14 weeks as per screening ultrasound.

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12 exclusion criteria prevent from participating

Known allergy/sensitivity, intolerance, or any hypersensitivity to components of study TB drugs or their formulation.

Documentation of Karnofsky Performance Status Score < 50 obtained within 14 days prior to study entry.

Known resistance to bedaquiline, pretomanid, delamanid, linezolid, or fluoroquinolones.

Previous use of any second-line anti-TB drugs for more than 14 days during the 12 months prior to the screening visit date.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

17 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (4BPaLM). Bedaquiline 400 mg orally once daily for 2 weeks, then 200 mg once daily; pretomanid 200 mg orally once daily; linezolid 600 mg orally once daily; and moxifloxacin 400 mg orally once daily.

Group II

Experimental

13 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (3BPaLM) for participants classified as having easier-to-treat TB and 24 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (6BPaLM) for participants classified as having harder-to-treat TB. 3BPaLM: 13 weeks of bedaquiline 400 mg orally once daily for 2 weeks, then 200 mg once daily; pretomanid 200 mg orally once daily, linezolid 600 mg orally once daily, and moxifloxacin 400 mg orally once daily. 6BPaLM: 24 weeks of bedaquiline 400 mg orally once daily for 2 weeks, then 200 mg once daily; pretomanid 200 mg orally once daily, linezolid 600 mg orally once daily, and moxifloxacin 400 mg orally once daily.

Group III

Active Comparator

The local SOC regimen consistent with preferred regimen(s) in international guidelines. In most cases this will be 24 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (6BPaLM). Doses and durations of each component may change based on the latest international guidelines and the local SOC.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Recruiting

National Center for Communicable Diseases

Ulaanbaatar, MongoliaOpen National Center for Communicable Diseases in Google Maps

Recruiting soon

Institute of Chest Diseases

Kotri, Pakistan

Recruiting soon

Hospital Nacional Sergio E. Bernales

Lima, Peru

Recruiting soon

Policlínico SES

Lima, Peru

Recruiting

6 Study Centers