Evidence map›Paper›PMID 40064371›Full record

ArticleContemporary clinical trials2025

Study protocol for a duration-randomized clinical trial to determine the optimal length of treatment for multidrug-resistant tuberculosis with a 5-drug regimen: The DRAMATIC trial.

Pawandeep Kaur, Lelia H Chaisson, Zana Wangari Kiragu, Praewpannarai Buddadhumaruk, Ariana F Austin, Yilan Gao, Veronika J Wirtz, Robert D Arbeit, Krystle Bliss Fetalvero, Hoa Binh Nguyen and 11 more

Abstract 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. 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

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

21 authors.

Pawandeep KaurDepartment of Global Health, Boston University School of Public Health, Boston, MA, USA.
Lelia H ChaissonUCSF Center for Tuberculosis, University of California, San Francisco, San Francisco, California, USA; UCSF Institute for Global Health Sciences, University of California, San Francisco, San Francisco, California, USA.
Zana Wangari KiraguDepartment of Global Health, Boston University School of Public Health, Boston, MA, USA.
Praewpannarai BuddadhumarukUCSF Center for Tuberculosis, University of California, San Francisco, San Francisco, California, USA; Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.
Ariana F AustinUCSF Center for Tuberculosis, University of California, San Francisco, San Francisco, California, USA; UCSF Institute for Global Health Sciences, University of California, San Francisco, San Francisco, California, USA.
Yilan GaoDepartment of Global Health, Boston University School of Public Health, Boston, MA, USA.
Veronika J WirtzDepartment of Global Health, Boston University School of Public Health, Boston, MA, USA.
Robert D ArbeitDivision of Geographic Medicine and Infectious Diseases, Tufts University School of Medicine and Tufts Medical Center, Boston, MA, USA.
Krystle Bliss FetalveroDe La Salle Medical and Health Sciences Institute, Das Mariñas, Philippines.
Hoa Binh NguyenNational Lung Hospital/National Tuberculosis Control Programme, Ha Noi, Viet Nam.
Nhung Viet NguyenUniversity of Medicine and Pharmacy, Vietnam National University, Ha Noi, Viet Nam.
Huy HaHanoi Lung Hospital/National Tuberculosis Control Programme, Ha Noi, Viet Nam; Center for Promotion of Advancement of Society, Ha Noi, Viet Nam.
Kathleen EisenachTB or NOT TB Consulting, LLC, Little Rock, AR, USA.
Nicholas D WalterRocky Mountain Regional VA Medical Center, Aurora, CO, USA.; Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.; Consortium for Applied Microbial Metrics, Aurora, CO, USA.
Carole D MitnickDivision of Global Health Equity, Brigham and Women's Hospital, Boston, MA, USA; Partners in Health, 800 Boylston Street Suite 300, Boston, MA, USA.; Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA.
Maria Tarcela S GlerDe La Salle Medical and Health Sciences Institute, Das Mariñas, Philippines.
Ha PhanCenter for Promotion of Advancement of Society, Ha Noi, Viet Nam; Vietnam Tuberculosis Program/University of California, San Francisco Research Collaboration Unit, Ha Noi, Viet Nam.
Payam NahidUCSF Center for Tuberculosis, University of California, San Francisco, San Francisco, California, USA; UCSF Institute for Global Health Sciences, University of California, San Francisco, San Francisco, California, USA; Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.
Patrick P J PhillipsUCSF Center for Tuberculosis, University of California, San Francisco, San Francisco, California, USA; Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of California, San Francisco, San Francisco, California, USA; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California, USA.
C Robert HorsburghDepartment of Global Health, Boston University School of Public Health, Boston, MA, USA; Department of Epidemiology and Department of Biostatistics, Boston University School of Public Health, Boston, MA, USA; Department of Medicine, Boston University Chobanian and Avedisian School of Medicine, Boston, MA, USA.
Gustavo E VelásquezUCSF Center for Tuberculosis, University of California, San Francisco, San Francisco, California, USA; Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco, San Francisco, California, USA. Electronic address: gustavo.velasquez@ucsf.edu.

Funding

DRAMATIC Phase 2 Duration Randomized MDR-TB Treatment TrialU01AI152980 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Charles Robert Horsburgh, PAYAM NAHID · 2020 to 2026
$7.5M
NIAID NIH HHS U01 AI152980
6 · The paper itself

Abstract

backgroundCurrent guidelines for the treatment of multidrug-resistant/rifampin-resistant tuberculosis (MDR/RR-TB) are based on clinical trials evaluating fixed duration regimens. However, when a regimen succeeds, it remains unknown whether a shorter duration could yield the same results. Similarly, if a regimen fails, it is unclear whether extending the treatment could improve outcomes. Trials are needed to assess the relationship between various treatment durations and outcomes. METHODS/

designWe designed a duration-randomized trial of treatment for fluoroquinolone-susceptible MDR/RR-TB. The DRAMATIC (Duration Randomized Anti-MDR-TB And Tailored Intervention Clinical) Trial is a multicenter, randomized, partially blinded, four-arm, phase 2 trial that examines an all oral, pyrazinamide-free regimen of bedaquiline, clofazimine, delamanid, linezolid, and levofloxacin, with administration of linezolid only in the initial 16 weeks of treatment. The four trial arms are treatment durations of 16, 24, 32 and 40 weeks. Randomization is stratified by "extensive" or "non-extensive" disease based on baseline smear (or Xpert) and cavitary status. The primary endpoint is relapse-free survival at week 76. The target sample size is 220. Participants are being enrolled in sites in the Philippines and Vietnam. The expected output will be an equation describing the relationship between treatment duration and the proportion of participants with relapse-free survival. DISCUSSION: This trial aims to demonstrate that a duration-response relationship can be described for the treatment of MDR/RR-TB by a duration-randomized trial.

Indexed as

Antitubercular AgentsTuberculosis, Multidrug-ResistantClinical Trials, Phase II as TopicClofazimineDiarylquinolinesDrug Administration ScheduleDrug Therapy, CombinationHumansLevofloxacinLinezolidMulticenter Studies as TopicNitroimidazolesOxazolesPyrazinamideRandomized Controlled Trials as TopicTreatment OutcomeAntitubercular AgentsbedaquilineClofazimineDiarylquinolinesLevofloxacinLinezolidNitroimidazolesOPC-67683OxazolesPyrazinamideBedaquilineClinical trialClofazimineDelamanidDuration randomizationLevofloxacinLinezolidMultidrug-resistant tuberculosis

Identifiers

PMID40064371
PMCPMC12083089

What OpenQuestion holds

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Registered trials

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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.