The goal of this clinical trial is to learn if adding contezolid works to shorten the length of treatment in mycobacterium avium pulmonary disease in adults. It will also learn about the safety of extended usage of contezolid. The main questions it aims to answer are: Does adding contezolid to standard regimen decrease the bacterial load, lesion severity and improve the life quality of patients with mycobacterium avium pulmonary disease? What medical problems do participants have when taking contezolid for an extended length? Researchers will compare standard regimen plus contezolid to standard regimen alone to see if contezolid helps further decrease the bacterial load, lesion severity and improve the life quality of patients with mycobacterium avium pulmonary disease? Participants will: Take contezolid and standard regimen (azithromycin, ethambutol, and rifampicin) for 6 months, contezolid is administered every day while other drugs are taken three times a week OR take standard regimen three times a week for 12 months. Visit the clinic once every 1 month for checkups and tests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
contezolid 800mg po q12h\*6m
azithromycin 500mg po tiw (250mg po tiw for BW under 50kg)\*6m
azithromycin 500mg po tiw (250mg po tiw for BW under 50kg)\*12m
ethambutol 25mg/kg po tiw\*6m
ethambutol 25mg/kg po tiw\*12m
rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)\*6m
rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)\*12m
Anhui Chest Hospital
Hefei, Anhui, China
RECRUITINGBeijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGChina-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGGuangzhou Chest Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGJiangxi Chest Hospital
Nanchang, Jiangxi, China
RECRUITINGShanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGculture conversion
2 consecutive negative sputum mycobacterial culture at least 4 weeks apart, or one negative bronchoalveolar lavage fluid culture/NGS.
Time frame: end of month 6
CT lesion absorption
\>30% decrease in lesion size or number of nodules measured on CT
Time frame: end of month 6
QOL-B+NTM module
Improvement greater than MID in at least 7 out of 12 domains in QOL-B with NTM-module (must include respiratory symptoms and NTM-PD symptoms)
Time frame: end of month 6
culture conversion
2 consecutive negative sputum mycobacterial culture at least 4 weeks apart, or one negative bronchoalveolar lavage fluid culture/NGS.
Time frame: up to month 12
CT lesion status
\>30% decrease in lesion size or number of nodules measured on CT
Time frame: end of month 3, 6, and 12 (for standard regimen)/end of month 3 and 6 (for shortened regimen)
Questionnaire: Quality of life-bronchiectasis (QOL-B) and NTM module
Improvement greater than minimal importance difference in at least 7 out of 12 domains in QOL-B with NTM module (must include respiratory symptoms and NTM-PD symptoms)
Time frame: up to month 12
SGRQ
Time frame: up to month 12
time to positivity of mycobacterium culture
Time frame: up to month 12
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