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"Aditia, Dedy"
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Efficacy and safety of 8-week regimens for the treatment of rifampicin-susceptible pulmonary tuberculosis (TRUNCATE-TB): a prespecified exploratory analysis of a multi-arm, multi-stage, open-label, randomised controlled trial
2025
WHO recommends a 2-month optimal duration for new drug regimens for rifampicin-susceptible tuberculosis. We aimed to investigate the efficacy and safety of the 8-week regimens that were assessed as part of the TRUNCATE management strategy of the TRUNCATE-TB trial.
TRUNCATE-TB was a multi-arm, multi-stage, open-label, randomised controlled trial in which participants aged 18–65 years with rifampicin-susceptible pulmonary tuberculosis were randomly assigned via a web-based system, using permuted blocks, to 24-week standard treatment (rifampicin, isoniazid, pyrazinamide, and ethambutol) or the TRUNCATE management strategy comprising initial 8-week treatment, then post-treatment monitoring and re-treatment where needed. The four 8-week regimens comprised five drugs, modified from standard treatment: high-dose rifampicin and linezolid, or high-dose rifampicin and clofazimine, or bedaquiline and linezolid, all given with isoniazid, pyrazinamide, and ethambutol; and rifapentine, linezolid, and levofloxacin, given with isoniazid and pyrazinamide. Here, we report the efficacy (proportion with unfavourable outcome; and difference from standard treatment, assessed via Bayesian methods) and safety of the 8-week regimens, assessed in the intention-to-treat population. This prespecified exploratory analysis is distinct from the previously reported 96-week outcome of the strategy in which the regimens were deployed. This trial is registered with ClinicalTrials.gov (NCT03474198).
Between March 21, 2018, and March 26, 2020, 675 participants (674 in the intention-to-treat population) were enrolled and randomly assigned to the standard treatment group or one of the four 8-week regimen groups. Two 8-week regimens progressed to full enrolment. An unfavourable outcome (mainly relapse) occurred in seven (4%) of 181 participants on standard treatment; 46 (25%) of 184 on the high-dose rifampicin and linezolid-containing regimen (adjusted difference 21·0%, 95% Bayesian credible interval [BCI] 14·3–28·1); and 26 (14%) of 189 on the bedaquiline and linezolid-containing regimen (adjusted difference 9·3% [4·3–14·9]). Grade 3–4 adverse events occurred in 24 (14%) of 181 participants on standard treatment, 20 (11%) of 184 on the rifampicin-linezolid regimen, and 22 (12%) of 189 on the bedaquiline-linezolid regimen.
Efficacy was worse with 8-week regimens, although the difference from standard treatment varied between regimens. Even the best 8-week regimen (bedaquiline-linezolid) should only be used as part of a management strategy involving post-treatment monitoring and re-treatment if necessary.
Singapore National Medical Research Council; UK Department of Health and Social Care; UK Foreign, Commonwealth, and Development Office; UK Medical Research Council; Wellcome Trust; and UK Research and Innovation Medical Research Council.
Journal Article
Understanding the technology acceptance model in the QRIS usage: Evidence from SMEs in Indonesia
by
Husrizal Syah, Dedy
,
Wahyu Nugrahadi, Eko
,
Rahman Dongoran, Faisal
in
Acceptance
,
Attitudes
,
Bank accounts
2022
This study aims to examine the Technology Acceptance Model (TAM) for QRIS usage in SMEs in Indonesia. We employed Partial Least Square Structural Equation Modelling (PLS-SEM) with a first-order reflective model to analyze the data. The dataset contains 107 SMEs in Medan, Indonesia (n = 107). There are four constructs in the model in this study, namely: perceived usefulness, perceived ease of use, attitude toward using, and behavioral intention to use. After evaluating measurement models and structural models known to meet the criteria, we can conclude the results of the data analysis. In general, all variables positively affect other variables in this model, although one of them is insignificant. The results indicate that perceived usefulness is positive and significantly affects attitude toward using and behavioral intention to use. At the same time, attitude toward using is also positive and significantly affects behavioral intention to use. Furthermore, perceived ease of use is also shown to have a positive and significant effect on attitude toward using and perceived usefulness. However, perceived ease of use insignificantly affects behavioral intention to use, although it still positively affects the behavioral intention to use. The findings of this study provide some crucial implications for SMEs and the provider of QRIS. Since the results indicate welcoming QRIS usage, the socialization of QRIS needs to be more massive to reach the vast majority of Indonesian SMEs in Indonesia.
Journal Article