Evidence map›Paper›PMID 39343425›Full record

ArticleTuberculosis and respiratory diseases2025

High-Dose Rifampicin for 3 Months after Culture Conversion for Drug-Susceptible Pulmonary Tuberculosis.

Nakwon Kwak, Joong-Yub Kim, Hyung-Jun Kim, Byoung-Soo Kwon, Jae Ho Lee, Jeongha Mok, Yong-Soo Kwon, Young Ae Kang, Youngmok Park, Ji Yeon Lee and 10 more

Registry-linked trialAbstract read
In one paragraph

Article in Tuberculosis and respiratory diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04485156 (Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin to 3 Months After Culture Conversion), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT04485156 phase3not yet recruitingnot on this map

Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin to 3 Months After Culture Conversion (Hi-DoRi-3): A Phase 3, Multicenter, Randomized, Open-label, Clinical Trial

TypeinterventionalSponsorSeoul National University HospitalRan2020 to 2026Enrolled926ConditionsTuberculosis, PulmonaryArmsHigh-dose rifampicin, Isoniazid, Pyrazinamide, Ethambutol, Rifampicin
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
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

20 authors.

Nakwon KwakDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Joong-Yub KimDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Hyung-Jun KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Byoung-Soo KwonDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Jae Ho LeeDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Jeongha MokDepartment of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Republic of Korea.
Yong-Soo KwonDepartment of Internal Medicine, Chonnam National University Hospital, Gwangju, Republic of Korea.
Young Ae KangDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Youngmok ParkDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Ji Yeon LeeDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, National Medical Center, Seoul, Republic of Korea.
Doosoo JeonDepartment of Internal Medicine, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan, Republic of Korea.
Jung-Kyu LeeDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Jeong Seong YangResearch and Development Center, The Korean Institute of Tuberculosis, Cheongju, Republic of Korea.
Jake WhangResearch and Development Center, The Korean Institute of Tuberculosis, Cheongju, Republic of Korea.
Kyung Jong KimResearch and Development Center, The Korean Institute of Tuberculosis, Cheongju, Republic of Korea.
Young Ran KimClinical Research Section, International Tuberculosis Research Center, Seoul, Republic of Korea.
Minkyoung CheonMedical Research Collaborating Center, Seoul National University Hospital, Seoul, Republic of Korea.
Jiwon ParkMedical Research Collaborating Center, Seoul National University Hospital, Seoul, Republic of Korea.
Seokyung HahnMedical Research Collaborating Center, Seoul National University Hospital, Seoul, Republic of Korea.
Jae-Joon YimDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.

Funding

Korea National Institute of Health 2020-ER5201-02
6 · The paper itself

Abstract

backgroundThis study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen.

methodsThis multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156).

resultsBetween 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups.

conclusionThe shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.

Indexed as

High-Dose RifampicinTreatment ShorteningTuberculosis

Identifiers

PMID39343425
PMCPMC11704738

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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.