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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

Authors
 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  ;  Ji Yeon Lee  ;  Jung-Kyu Lee  ;  Jeongha Mok  ;  Minkyoung Cheon  ;  Jiwon Park  ;  Seokyung Hahn  ;  Jae-Joon Yim 
Citation
 TRIALS, Vol.23(1) : 666, 2022-08 
Journal Title
TRIALS
Issue Date
2022-08
MeSH
Antitubercular Agents / adverse effects ; Drug Therapy, Combination / adverse effects ; Humans ; Isoniazid / adverse effects ; Multicenter Studies as Topic ; Pyrazinamide / adverse effects ; Randomized Controlled Trials as Topic ; Rifampin* / adverse effects ; Treatment Outcome ; Tuberculosis, Pulmonary* / diagnosis ; Tuberculosis, Pulmonary* / drug therapy
Keywords
Rifampicin ; Shorter regimen ; Tuberculosis
Abstract
Background: The 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.

Methods: This 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 registration: ClinicalTrials.gov NCT04485156 . Registered on July 24, 2020.
Files in This Item:
T202203438.pdf Download
DOI
10.1186/s13063-022-06631-z
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kang, Young Ae(강영애) ORCID logo https://orcid.org/0000-0002-7783-5271
Park, Youngmok(박영목) ORCID logo https://orcid.org/0000-0002-5669-1491
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/191908
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