Evidence map›Paper›PMID 39477924›Full record

Trial reportNature communications2024

Risk-stratified treatment for drug-susceptible pulmonary tuberculosis.

Vincent K Chang, Marjorie Z Imperial, Patrick P J Phillips, Gustavo E Velásquez, Payam Nahid, Andrew Vernon, Ekaterina V Kurbatova, Susan Swindells, Richard E Chaisson, Susan E Dorman and 18 more

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Nature communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02410772 (Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02410772 phase3completednot on this map

Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled Phase 3 Clinical Trial. TBTC Study 31, ACTG Study A5349

TypeinterventionalSponsorCenters for Disease Control and PreventionRan2016 to 2021Enrolled2,516ConditionsTuberculosisArmsrifapentine, rifapentine and moxifloxacin, control
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Insights into the Role of Rifampicin Exposure and Clinical Baseline Covariates on the Response to Pulmonary Tuberculosis Treatment.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  5. Future Prospects for Using Clinical Phenotypes in Tuberculosis Precision Medicine-An Approach for Clinical Management.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Review
  6. Article
  7. Article
  8. New drugs for the management of tuberculosis.Current opinion in infectious diseases · 2025
    Review
  9. Article
  10. Review
  11. Article
  12. Anti-TB Drugs for Drug-Sensitive and Drug-ResistantCurrent issues in molecular biology · 2025
    Review
  13. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors.

Vincent K ChangDepartment of Bioengineering and Therapeutic Sciences, University of California San Francisco, San Francisco, CA, USA.
Marjorie Z ImperialDepartment of Bioengineering and Therapeutic Sciences, University of California San Francisco, San Francisco, CA, USA.
Patrick P J PhillipsUCSF Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.ORCID 0000-0002-6336-7024
Gustavo E VelásquezUCSF Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.
Payam NahidUCSF Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.
Andrew VernonCenters for Disease Control and Prevention, Atlanta, GA, USA.
Ekaterina V KurbatovaCenters for Disease Control and Prevention, Atlanta, GA, USA.
Susan SwindellsUniversity of Nebraska Medical Center, Omaha, NE, USA.
Richard E ChaissonCenter for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MA, USA.ORCID 0000-0003-4710-925X
Susan E DormanMedical University of South Carolina, Charleston, SC, USA.
John L JohnsonCase Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.ORCID 0000-0003-1783-0476
Marc WeinerUniversity of Texas Health Science Center at San Antonio and the South Texas Veterans Health Care System, San Antonio, TX, USA.
Amina JindaniSt. George's, University of London, London, UK.
Thomas HarrisonSt. George's, University of London, London, UK.
Erin E SizemoreCenters for Disease Control and Prevention, Atlanta, GA, USA.
William WhitworthCenters for Disease Control and Prevention, Atlanta, GA, USA.
Wendy CarrCenters for Disease Control and Prevention, Atlanta, GA, USA.
Kia E BryantCenters for Disease Control and Prevention, Atlanta, GA, USA.
Deron BurtonCenters for Disease Control and Prevention, Atlanta, GA, USA.
Kelly E DooleyDivision of Infectious Diseases, Vanderbilt University, Nashville, TN, USA.
Melissa EngleUniversity of Texas Health Science Center at San Antonio and the South Texas Veterans Health Care System, San Antonio, TX, USA.
Pheona NsubugaUganda-Case Western Reserve University Research Collaboration, Kampala, Uganda.
Andreas H DiaconTASK, Cape Town, Western Cape, Cape Town, South Africa.
Nguyen Viet NhungVietnam National Tuberculosis Program-University of California, San Francisco Research Collaboration Unit, Hanoi, Vietnam.
Rodney DawsonLung Institute and Division of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Radojka M SavicDepartment of Bioengineering and Therapeutic Sciences, University of California San Francisco, San Francisco, CA, USA. rada.savic@ucsf.edu.ORCID 0000-0003-3143-5579
AIDS Clinical Trial Group
Tuberculosis Trials Consortium

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
The Malawi Clinical Trials UnitUM1AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI JACKY M JENNINGS, TAHA E TAHA · 2012 to 2026
$43.8M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
Identifying Optimal Treatment Strategies for Tuberculosis TreatmentR01AI135124 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ALLAND, DAVID, SAVIC, RADOJKA · 2019 to 2023
$3.8M
Safety and tolerability of new and repurposed drugs for MDR-TB treatmentK08AI141740 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI VELASQUEZ, GUSTAVO EDUARDO · 2019 to 2023
$985k
Mentoring Investigators in HIV and Tuberculosis Therapeutics ResearchK24AI150349 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI DOOLEY, KELLY E. · 2020 to 2025
$789k
NIAID NIH HHS K08 AI141740NIAID NIH HHS K24 AI150349NIAID NIH HHS R01 AI135124NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI069518NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

The Phase 3 randomized controlled trial, TBTC Study 31/ACTG A5349 (NCT02410772) demonstrated that a 4-month rifapentine-moxifloxacin regimen for drug-susceptible pulmonary tuberculosis was safe and effective. The primary efficacy outcome was 12-month tuberculosis disease free survival, while the primary safety outcome was the proportion of grade 3 or higher adverse events during the treatment period. We conducted an analysis of demographic, clinical, microbiologic, radiographic, and pharmacokinetic data and identified risk factors for unfavorable outcomes and adverse events. Among participants receiving the rifapentine-moxifloxacin regimen, low rifapentine exposure is the strongest driver of tuberculosis-related unfavorable outcomes (HR 0.65 for every 100 µg∙h/mL increase, 95%CI 0.54-0.77). The only other risk factors identified are markers of higher baseline disease severity, namely Xpert MTB/RIF cycle threshold and extent of disease on baseline chest radiography (Xpert: HR 1.43 for every 3-cycle-threshold decrease, 95%CI 1.07-1.91; extensive disease: HR 2.02, 95%CI 1.07-3.82). From these risk factors, we developed a simple risk stratification to classify disease phenotypes as easier-, moderately-harder, or harder-to-treat TB. Notably, high rifapentine exposures are not associated with any predefined adverse safety outcomes. Our results suggest that the easier-to-treat subgroup may be eligible for further treatment shortening while the harder-to-treat subgroup may need higher doses or longer treatment.

Indexed as

Antitubercular AgentsRifampinTuberculosis, PulmonaryAdultDrug Therapy, CombinationFemaleHumansMaleMiddle AgedMoxifloxacinMycobacterium tuberculosisRisk FactorsTreatment OutcomeYoung AdultAntitubercular AgentsMoxifloxacinRifampinrifapentine

Identifiers

PMID39477924
PMCPMC11526018

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.