Evidence map›Paper›PMID 40915316›Full record

ArticleContemporary clinical trials2025

Phase 2C clinical trial of novel short-course regimens for the treatment of pulmonary tuberculosis: TBTC study 38/CRUSH-TB design.

Ekaterina V Kurbatova, Kelly E Dooley, Wendy Carr, Jason E Stout, Eric L Nuermberger, Patrick P J Phillips, Nigel A Scott, Caryn M Upton, Elisa Ignatius, Michelle Haas and 18 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05766267 (Phase 2C Clinical Trial of Novel, Short-course Regimens for the Treatment of Pulmonary Tuberculosis), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

NCT05766267 phase2 / phase3active not recruitingnot on this map

Phase 2C Clinical Trial of Novel, Short-course Regimens for the Treatment of Pulmonary Tuberculosis: CRUSH-TB (Combination Regimens for Shortening TB Treatment)

TypeinterventionalSponsorCenters for Disease Control and PreventionRan2023 to 2027Enrolled288ConditionsTuberculosis, Pulmonary, Tuberculosis InfectionArmsRifabutin, Delamanid, Bedaquiline, Moxifloxacin, Pyrazinamide
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

Ekaterina V KurbatovaCenters for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: ies3@cdc.gov.
Kelly E DooleyVanderbilt University Medical Center, Nashville, TN, USA.
Wendy CarrCenters for Disease Control and Prevention, Atlanta, GA, USA.
Jason E StoutDuke University, Durham, NC, USA.
Eric L NuermbergerCenter for Tuberculosis Research, Johns Hopkins University, Baltimore, MD, USA.
Patrick P J PhillipsUCSF Center for Tuberculosis, University of California, San Francisco, CA, USA.
Nigel A ScottCenters for Disease Control and Prevention, Atlanta, GA, USA.
Caryn M UptonTASK Applied Science Brooklyn Chest Hospital, Cape Town, South Africa.
Elisa IgnatiusCenter for Tuberculosis Research, Johns Hopkins University, Baltimore, MD, USA.
Michelle HaasDivision of Infectious Diseases, Department of Medicine, University of Colorado Anschutz Medical Campus, Denver, CO, USA.
Nicholas D WalterUniversity of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Rita M TraxlerCenters for Disease Control and Prevention, Atlanta, GA, USA.
Nicole E BrownCenters for Disease Control and Prevention, Atlanta, GA, USA.
Rosanna BoydCenters for Disease Control and Prevention, Atlanta, GA, USA.
Kia E BryantCenters for Disease Control and Prevention, Atlanta, GA, USA.
Meredith G DixonCenters for Disease Control and Prevention, Atlanta, GA, USA.
Rada SavicUCSF Center for Tuberculosis, University of California, San Francisco, CA, USA.
Christie EichbergMedical University of South Carolina, Department of Medicine, Division of Infectious Disease, Charleston, SC, USA.
Anneke HesselingDepartment of Paediatrics and Child Health, Desmond Tutu Tuberculosis Centre, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa.
Charles BarkTuberculosis Research Unit, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Debra A BenatorVeterans Affairs Medical Center and the George Washington University, Washington, DC, USA; The George Washington University, Washington, DC, USA.
Grace MuzanyiUganda-Case Western Reserve University Research Collaboration, Kampala, Uganda.
Nicholas S TwycrossDivision of Pulmonology and Department of Medicine, University of Cape Town Lung Institute, Cape Town, South Africa.
Greg J FoxFaculty of Medicine and Health, The University of Sydney, Sydney, Australia.
Samuel PierreGHESKIO, Port-au-Prince, Haiti.
Joseph BurzynskiBureau of Tuberculosis Control, New York City Department of Health and Mental Hygiene, Queens, NY, USA.
Daniel W FitzgeraldWeill Cornell Medicine Center for Global Health, New York, NY, USA.
TBTC Study 38 CRUSH-TB Team

Funding

Preclinical Design and Clinical Translation of TB Regimens (PReDicTR) ConsortiumUM1AI179699 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Kelly E. Dooley, ERIC L NUERMBERGER · 2024 to 2026
$22.2M
Vanderbilt-Emory-Cornell-Duke Global Health Fellowship Consortium-Expanding Diversity for Global Equity (EDGE)D43TW009337 · FIC · VANDERBILT UNIVERSITY MEDICAL CENTER · PI ALIYU, MUKTAR HASSAN, HEIMBURGER, DOUGLAS CORBETT · 2017 to 2021
$6.3M
Optimizing Anti-mycobacterial Therapy Using A Pharmacology-based ApproachK23AI159145 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Elisa Helen Ignatius · 2022 to 2026
$994k
Mentoring Investigators in HIV and Tuberculosis Therapeutics ResearchK24AI150349 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI DOOLEY, KELLY E. · 2020 to 2025
$789k
FIC NIH HHS D43 TW009337Intramural CDC HHS CC999999NIAID NIH HHS K23 AI159145NIAID NIH HHS K24 AI150349NIAID NIH HHS UM1 AI179699
6 · The paper itself

Abstract

introductionPreclinical and clinical study data show that combining bedaquiline (B or BDQ), moxifloxacin (M), and pyrazinamide (Z), known as BMZ, has potent antimicrobial activity that might shorten treatment duration for drug-susceptible pulmonary tuberculosis. METHODS/

designWe describe the design of Tuberculosis Trials Consortium (TBTC) Study 38/CRUSH-TB (NCT05766267), an open-label multicenter international randomized controlled phase 2C trial that compares two four-month regimens, BMZ plus rifabutin (Rb) (2BMZRb/2BMRb) or BMZ plus delamanid (D or DLM) (2BMZD/2BMD), with standard 6-months isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE). All drugs are administered seven days per week, under direct observation, at least five days per week. A total of 288 participants, aged ≥12 years, newly diagnosed with sputum smear-positive or Xpert MTB/RIF (Ultra)-positive drug-susceptible pulmonary tuberculosis, will be randomized 1:1:1 to receive BMZRb, BMZD, or HRZE. Participants are followed until 78 weeks post-randomization, or until the last enrolled participant completes 52 weeks post-randomization, whichever comes first. The primary endpoint is time to sputum culture negative in liquid media. Secondary endpoints include sustained cure, safety, and additional mycobacteriology and pharmacokinetic and pharmacodynamic outcomes. This trial has an adaptive design, wherein new arms can be added. DISCUSSION: This trial tests the hypothesis whether four-month BMZ-based regimens with Rb or D can shorten time to culture negativity while being safe and tolerable for participants. The study design is adaptive, allowing for additional study arms as new drugs become available. Findings from this trial might have important implications for clinically managing drug-susceptible pulmonary tuberculosis at individual and programmatic levels. Trial registration IND Number: 158058. IND Sponsor: U.S. Centers for Disease Control and Prevention. CLINICALTRIALS: govIdentifier:NCT05766267. Registered 13 March 2023, https://classic. CLINICALTRIALS: gov/ct2/show/NCT05766267.

Indexed as

Antitubercular AgentsTuberculosis, PulmonaryAdolescentAdultClinical Trials, Phase II as TopicDiarylquinolinesDrug Administration ScheduleDrug Therapy, CombinationEthambutolFemaleHumansIsoniazidMaleMiddle AgedMoxifloxacinMulticenter Studies as TopicAntitubercular AgentsbedaquilineDiarylquinolinesEthambutolIsoniazidMoxifloxacinNitroimidazolesOPC-67683OxazolesPyrazinamideRifabutinRifampinBedaquilineDelamanidRandomized clinical trialRifabutinTBTuberculosis

Identifiers

PMID40915316
PMCPMC12668207

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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.