NCT07213765

Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Bin Cao · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Mycobacterium Avium Complex Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Contezolid	contezolid 800mg po q12h\*6m
DRUG	Azithromycin	azithromycin 500mg po tiw (250mg po tiw for BW under 50kg)\*6m
DRUG	Azithromycin	azithromycin 500mg po tiw (250mg po tiw for BW under 50kg)\*12m
DRUG	Ethambutol (E)	ethambutol 25mg/kg po tiw\*6m
DRUG	Ethambutol (E)	ethambutol 25mg/kg po tiw\*12m
DRUG	Rifampicin (R)	rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)\*6m
DRUG	Rifampicin (R)	rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)\*12m

Timeline

• Start date: 2025-07-24
• Primary completion: 2028-09-30
• Completion: 2028-12-31
• First posted: 2025-10-09
• Last updated: 2025-10-09

Locations

6 sites across 1 country: China