scholarly journals 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

2019 ◽  
Vol 6 (1) ◽  
pp. e000434 ◽  
Author(s):  
Taku Nakagawa ◽  
Hiroya Hashimoto ◽  
Mitsuaki Yagi ◽  
Yoshihito Kogure ◽  
Masahiro Sekimizu ◽  
...  
Keyword(s):  
Treatment Group ◽  
Lung Disease ◽  
Treatment Regimen ◽  
Mycobacterium Avium ◽  
Drug Combination ◽  
Daily Treatment ◽  
Intermittent Treatment ◽  
Sputum Culture Conversion ◽  
Randomised Controlled ◽  
Culture Conversion

IntroductionStandard 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 analysisA 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 disseminationThis 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.

scholarly journals Intermittent Treatment with Azithromycin and Ethambutol for Noncavitary Mycobacterium avium Complex Pulmonary Disease

2019 ◽  
Vol 64 (1) ◽  
Author(s):  
Seong Mi Moon ◽  
In Young Yoo ◽  
Hee Jae Huh ◽  
Nam Yong Lee ◽  
Byung Woo Jhun
Keyword(s):  
Pulmonary Disease ◽  
Mycobacterium Avium ◽  
Odds Ratio ◽  
Mycobacterium Avium Complex ◽  
Adjusted Odds Ratio ◽  
Sputum Smear ◽  
Intermittent Treatment ◽  
Content Type ◽  
Sputum Culture Conversion ◽  
Culture Conversion

ABSTRACT We evaluated the efficacy of intermittent azithromycin and ethambutol therapy for noncavitary Mycobacterium avium complex pulmonary disease (MAC-PD). Twenty-nine (76%) of 38 patients achieved sputum culture conversion after 12 months of treatment, and sputum smear positivity was an independent factor for failure to achieve culture conversion (adjusted odds ratio, 26.7; 95% confidence interval, 2.1 to 339.9; P = 0.011). Intermittent azithromycin and ethambutol may be an optional treatment regimen for noncavitary MAC-PD.

scholarly journals An Intensified Regimen Containing Linezolid Could Improve Treatment Response in Mycobacterium abscessus Lung Disease

2019 ◽  
Vol 2019 ◽  
pp. 1-5
Author(s):  
Hua Li ◽  
Li Tong ◽  
Jun Wang ◽  
Qingtao Liang ◽  
Yun Zhang ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Lung Disease ◽  
Treatment Response ◽  
Conversion Rate ◽  
Mycobacterium Abscessus ◽  
Sputum Culture Conversion ◽  
Conventional Regimen ◽  
Sputum Conversion ◽  
Culture Conversion

Background. Treatment response for the Mycobacterium abscessus (M. abscessus) lung disease remains far from satisfying. An effective regimen is needed to solve the problem. Methods. We retrospectively reviewed the medical records of all patients with M. abscessus lung disease who received antibiotics regimen at Beijing Chest Hospital Affiliated to Capital Medical University between July 1, 2010, and February 1, 2018. Patients were administered a conventional antibiotics regimen (including macrolide and moxifloxacin, along with an initial 12-week course of low-dose cefoxitin and amikacin) or intensified regimen (including a higher dosage of cefoxitin and linezolid besides conventional drugs), respectively. The time to sputum-culture conversion and proportion of sputum-culture conversion in liquid broth were investigated to evaluate the efficacy and evaluation of safety by performing the classification of adverse events according to the Division of AIDS, National Institute of Allergy and Infectious Disease. Patients were followed for 18 months from baseline. Results. In the conventional regimen group, the sputum conversion rate at 18 months was 29.4% (10/34), and the median time until sputum conversion was 2 months (IQR, 1-2 mo). Furthermore, in the intensified regimen group, the sputum conversion rate was 81.3% (13/16), and the median time until sputum conversion was 1 month (IQR, 1-1 mo). Leukopenia and drug-induced hepatotoxicity occurred more frequently in the intensified regimen group in contrast with the conventional regimen group patients. However, only 1 adverse event in the intensified regimen group was classified as severe adverse event. Conclusions. The intensified regimen could improve sputum conversion of M. abscessus lung disease compared with conventional regimen, but close safety surveillance is necessary to monitor adverse events.

Amikacin Liposome Inhalation Suspension for Mycobacterium avium Complex Lung Disease

2020 ◽  
Vol 35 (4) ◽  
pp. 162-170
Author(s):  
Austin Golia ◽  
Brenden R. Mahmood ◽  
Yaniset Fundora ◽  
Krisy-Ann Thornby ◽  
Elias B. Chahine
Keyword(s):  
Clinical Trial ◽  
Lung Disease ◽  
Mycobacterium Avium ◽  
Adverse Reactions ◽  
Data Extraction ◽  
Phase Iii ◽  
British Thoracic Society ◽  
Conversion Rates ◽  
Culture Conversion

OBJECTIVE: To review the pharmacology, pharmacokinetics, pharmacodynamics, clinical efficacy, safety, administration, and role of amikacin liposome inhalation suspension (ALIS) in treatment of Mycobacterium avium complex (MAC) lung disease.<br/> DATA SOURCES: A PubMed search using the terms "amikacin inhaled," "nebulized," and "liposome suspension" was performed. Selected infectious diseaseconference posters were also examined for relevant information. In addition, pertinent guidelines were reviewed.<br/> STUDY SELECTION/DATA EXTRACTION: Guidelines for the management of nontuberculous mycobacterial infections from the American Thoracic Society/ Infectious Diseases Society of America and the British Thoracic Society were used to summarize guidelinebased therapy (GBT). A phase II and a phase III clinical trial were reviewed to evaluate the role of ALIS in the treatment of MAC lung disease.<br/> DATA SYNTHESIS: ALIS is a new formulation of inhaled amikacin (AMK) indicated for the treatment of MAC lung disease refractory to GBT in adults who are not candidates for intravenous AMK. An ongoing clinical trial has demonstrated that once-daily ALIS plus GBT results in higher rates of culture conversion compared with GBT alone by month 6 among patients with a mean age of 65 years. The most common adverse reactions associated with ALIS were dysphonia, cough, bronchospasm, hemoptysis, and ototoxicity. Nephrotoxicity was uncommon.<br/> CONCLUSION: ALIS has been shown to increase culture conversion rates when added to GBT in adults with difficult-to-treat MAC lung disease. ALIS is associated with high rates of pulmonary and auditory adverse reactions and a low risk of renal adverse reactions. ALIS may be an attractive treatment option for older adults who are at high risk for nephrotoxicity.

Amikacin Liposome Inhalation Suspension for Mycobacterium avium Complex Lung Disease

2020 ◽  
Vol 35 (4) ◽  
pp. 162-170
Author(s):  
Austin Golia ◽  
Brenden R. Mahmood ◽  
Yaniset Fundora ◽  
Krisy-Ann Thornby ◽  
Elias B. Chahine
Keyword(s):  
Clinical Trial ◽  
Lung Disease ◽  
Mycobacterium Avium ◽  
Adverse Reactions ◽  
Data Extraction ◽  
Phase Iii ◽  
British Thoracic Society ◽  
Conversion Rates ◽  
Culture Conversion

OBJECTIVE: To review the pharmacology, pharmacokinetics, pharmacodynamics, clinical efficacy, safety, administration, and role of amikacin liposome inhalation suspension (ALIS) in treatment of Mycobacterium avium complex (MAC) lung disease.<br/> DATA SOURCES: A PubMed search using the terms "amikacin inhaled," "nebulized," and "liposome suspension" was performed. Selected infectious diseaseconference posters were also examined for relevant information. In addition, pertinent guidelines were reviewed.<br/> STUDY SELECTION/DATA EXTRACTION: Guidelines for the management of nontuberculous mycobacterial infections from the American Thoracic Society/ Infectious Diseases Society of America and the British Thoracic Society were used to summarize guidelinebased therapy (GBT). A phase II and a phase III clinical trial were reviewed to evaluate the role of ALIS in the treatment of MAC lung disease.<br/> DATA SYNTHESIS: ALIS is a new formulation of inhaled amikacin (AMK) indicated for the treatment of MAC lung disease refractory to GBT in adults who are not candidates for intravenous AMK. An ongoing clinical trial has demonstrated that once-daily ALIS plus GBT results in higher rates of culture conversion compared with GBT alone by month 6 among patients with a mean age of 65 years. The most common adverse reactions associated with ALIS were dysphonia, cough, bronchospasm, hemoptysis, and ototoxicity. Nephrotoxicity was uncommon.<br/> CONCLUSION: ALIS has been shown to increase culture conversion rates when added to GBT in adults with difficult-to-treat MAC lung disease. ALIS is associated with high rates of pulmonary and auditory adverse reactions and a low risk of renal adverse reactions. ALIS may be an attractive treatment option for older adults who are at high risk for nephrotoxicity.

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