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Multicentre, open label, randomised controlled trial comparing intermittent versus daily treatment for non-cavitary nodular/bronchiectatic Mycobacterium avium complex lung disease with rifampicin, ethambutol and clarithromycin (iREC): study protocol
INTRODUCTION: Standard treatment for nodular/bronchiectatic Mycobacterium avium complex lung disease (NB MAC-LD), excluding severe-status cases, differs between Japan and other countries. Internationally, three-drug combination intermittent treatment (three times a week administration) with macrolid...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6561383/ https://www.ncbi.nlm.nih.gov/pubmed/31258920 http://dx.doi.org/10.1136/bmjresp-2019-000434 |
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author | Nakagawa, Taku Hashimoto, Hiroya Yagi, Mitsuaki Kogure, Yoshihito Sekimizu, Masahiro Saito, Akiko M Ogawa, Kenji Inoue, Yoshikazu |
author_facet | Nakagawa, Taku Hashimoto, Hiroya Yagi, Mitsuaki Kogure, Yoshihito Sekimizu, Masahiro Saito, Akiko M Ogawa, Kenji Inoue, Yoshikazu |
author_sort | Nakagawa, Taku |
collection | PubMed |
description | INTRODUCTION: Standard treatment for nodular/bronchiectatic Mycobacterium avium complex lung disease (NB MAC-LD), excluding severe-status cases, differs between Japan and other countries. Internationally, three-drug combination intermittent treatment (three times a week administration) with macrolide, ethambutol and rifampicin is recommended, but a daily treatment regimen is recommended in Japan. To date, no randomised controlled study directly comparing intermittent treatment with daily treatment has been performed. The purpose of this study is to investigate the usefulness of intermittent treatment. METHODS AND ANALYSIS: A total of 140 patients diagnosed with NB MAC-LD in Japan will be randomly assigned, in a 1:1 ratio, to intermittent treatment group or daily treatment group, and three-drug combination therapy with clarithromycin, rifampicin and ethambutol will be continued for 1 year. The primary endpoint is the proportion of patients requiring modification of the initial treatment regimen. Secondary endpoints are adverse events, sputum culture conversion, time to sputum culture conversion, improvement of chest CT findings, change in health-related quality of life score and development of clarithromycin resistance. ETHICS AND DISSEMINATION: This trial was approved by the National Hospital Organisation Review Board for Clinical Trials (Headquarters). The results of this study will be reported at a society meeting or published in a peer-review journal. |
format | Online Article Text |
id | pubmed-6561383 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-65613832019-06-28 Multicentre, open label, randomised controlled trial comparing intermittent versus daily treatment for non-cavitary nodular/bronchiectatic Mycobacterium avium complex lung disease with rifampicin, ethambutol and clarithromycin (iREC): study protocol Nakagawa, Taku Hashimoto, Hiroya Yagi, Mitsuaki Kogure, Yoshihito Sekimizu, Masahiro Saito, Akiko M Ogawa, Kenji Inoue, Yoshikazu BMJ Open Respir Res Respiratory Infection INTRODUCTION: Standard treatment for nodular/bronchiectatic Mycobacterium avium complex lung disease (NB MAC-LD), excluding severe-status cases, differs between Japan and other countries. Internationally, three-drug combination intermittent treatment (three times a week administration) with macrolide, ethambutol and rifampicin is recommended, but a daily treatment regimen is recommended in Japan. To date, no randomised controlled study directly comparing intermittent treatment with daily treatment has been performed. The purpose of this study is to investigate the usefulness of intermittent treatment. METHODS AND ANALYSIS: A total of 140 patients diagnosed with NB MAC-LD in Japan will be randomly assigned, in a 1:1 ratio, to intermittent treatment group or daily treatment group, and three-drug combination therapy with clarithromycin, rifampicin and ethambutol will be continued for 1 year. The primary endpoint is the proportion of patients requiring modification of the initial treatment regimen. Secondary endpoints are adverse events, sputum culture conversion, time to sputum culture conversion, improvement of chest CT findings, change in health-related quality of life score and development of clarithromycin resistance. ETHICS AND DISSEMINATION: This trial was approved by the National Hospital Organisation Review Board for Clinical Trials (Headquarters). The results of this study will be reported at a society meeting or published in a peer-review journal. BMJ Publishing Group 2019-05-30 /pmc/articles/PMC6561383/ /pubmed/31258920 http://dx.doi.org/10.1136/bmjresp-2019-000434 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Respiratory Infection Nakagawa, Taku Hashimoto, Hiroya Yagi, Mitsuaki Kogure, Yoshihito Sekimizu, Masahiro Saito, Akiko M Ogawa, Kenji Inoue, Yoshikazu Multicentre, open label, randomised controlled trial comparing intermittent versus daily treatment for non-cavitary nodular/bronchiectatic Mycobacterium avium complex lung disease with rifampicin, ethambutol and clarithromycin (iREC): study protocol |
title | Multicentre, open label, randomised controlled trial comparing intermittent versus daily treatment for non-cavitary nodular/bronchiectatic Mycobacterium avium complex lung disease with rifampicin, ethambutol and clarithromycin (iREC): study protocol |
title_full | Multicentre, open label, randomised controlled trial comparing intermittent versus daily treatment for non-cavitary nodular/bronchiectatic Mycobacterium avium complex lung disease with rifampicin, ethambutol and clarithromycin (iREC): study protocol |
title_fullStr | Multicentre, open label, randomised controlled trial comparing intermittent versus daily treatment for non-cavitary nodular/bronchiectatic Mycobacterium avium complex lung disease with rifampicin, ethambutol and clarithromycin (iREC): study protocol |
title_full_unstemmed | Multicentre, open label, randomised controlled trial comparing intermittent versus daily treatment for non-cavitary nodular/bronchiectatic Mycobacterium avium complex lung disease with rifampicin, ethambutol and clarithromycin (iREC): study protocol |
title_short | Multicentre, open label, randomised controlled trial comparing intermittent versus daily treatment for non-cavitary nodular/bronchiectatic Mycobacterium avium complex lung disease with rifampicin, ethambutol and clarithromycin (iREC): study protocol |
title_sort | multicentre, open label, randomised controlled trial comparing intermittent versus daily treatment for non-cavitary nodular/bronchiectatic mycobacterium avium complex lung disease with rifampicin, ethambutol and clarithromycin (irec): study protocol |
topic | Respiratory Infection |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6561383/ https://www.ncbi.nlm.nih.gov/pubmed/31258920 http://dx.doi.org/10.1136/bmjresp-2019-000434 |
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