Evidence map›Paper›PMID 35978342›Full record

ArticleTrials2022

Treatment shortening of drug-sensitive pulmonary tuberculosis using high-dose rifampicin for 3 months after culture conversion (Hi-DoRi-3): a study protocol for an open-label randomized clinical trial.

Nakwon Kwak, Doosoo Jeon, Youngmok Park, Young Ae Kang, Kyung Jong Kim, Young Ran Kim, Byoung Soo Kwon, Yong-Soo Kwon, Hyung-Jun Kim, Jae Ho Lee and 7 more

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

Article in Trials, 2022. 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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

17 authors.

Nakwon KwakDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.
Doosoo JeonDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, South Korea.
Youngmok ParkDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, South Korea.
Young Ae KangDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, South Korea.
Kyung Jong KimDepartment of R&D, Korean Institute of Tuberculosis, Cheongju, South Korea.
Young Ran KimClinical Research Section, International Tuberculosis Research Center, Seoul, South Korea.
Byoung Soo KwonDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
Yong-Soo KwonDepartment of Internal Medicine, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, South Korea.
Hyung-Jun KimDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
Jae Ho LeeDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
Ji Yeon LeeDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, National Medical Center, Seoul, South Korea.
Jung-Kyu LeeDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, South Korea.
Jeongha MokDivision of Pulmonology, Allergy and Critical Care Medicine, Department of Internal Medicine, Pusan National University Hospital, Busan, South Korea.
Minkyoung CheonMedical Research Collaborating Center, Seoul National University Hospital, Seoul, South Korea.
Jiwon ParkMedical Research Collaborating Center, Seoul National University Hospital, Seoul, South Korea.
Seokyung HahnMedical Research Collaborating Center, Seoul National University Hospital, Seoul, South Korea.
Jae-Joon YimDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea. yimjj@snu.ac.kr.

Funding

Korea National Institute of Health 2020-ER5201-01
6 · The paper itself

Abstract

backgroundThe standard treatment regimen for drug-sensitive tuberculosis (TB), comprising four companion drugs, requires a minimum duration of 6 months, and this lengthy treatment leads to poor adherence and increased toxicity. To improve rates of adherence, reduce adverse events, and lower costs, a simplified and shortened treatment regimen is warranted.

methodsThis study is a multicenter, open-label randomized clinical trial of non-inferiority design that compares a new regimen with the conventional regimen for drug-sensitive pulmonary TB. The investigational group will use a regimen of high-dose rifampicin (30 mg/kg/day) with isoniazid and pyrazinamide, and the treatment will be maintained for 12 weeks after the achievement of negative conversion of sputum culture. The control group will be treated for 6 months with a World Health Organization-endorsed regimen consisting of isoniazid, rifampicin (10 mg/kg/day), ethambutol, and pyrazinamide. The primary endpoint is the proportion of unfavorable outcomes at 18 months after randomization. Secondary outcomes include time to unfavorable treatment outcome, time to culture conversion on liquid medium, treatment success rate at the end of treatment, proportion of recurrence at 18 months after randomization, time to recurrence after treatment completion, and adverse events of grade 3 or higher during the treatment. We predict a 10% unfavorable outcome for the control group, and 0% difference from the investigational group. Based on 80% verification power and a 2.5% one-sided significance level for a non-inferiority margin of 6%, 393 participants per group are required. Considering the 15% dropout rate, a total of 926 participants (463 in each group) will be recruited. DISCUSSION: This study will inform on the feasibility of the treatment regimen using high-dose rifampicin with a shortened and individualized treatment duration for pulmonary TB.

trial registrationClinicalTrials.gov NCT04485156 . Registered on July 24, 2020.

Indexed as

RifampinTuberculosis, PulmonaryAntitubercular AgentsDrug Therapy, CombinationEquivalence Trials as TopicHumansIsoniazidMulticenter Studies as TopicPyrazinamideRandomized Controlled Trials as TopicTreatment OutcomeAntitubercular AgentsIsoniazidPyrazinamideRifampinRifampicinShorter regimenTuberculosis

Identifiers

PMID35978342
PMCPMC9387084

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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.