Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
China188 participantsStarted 2025-07-24
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients voluntarily participate in this study and sign the Informed Consent Form.
✓. Age ≥ 18 years and ≤75 years; gender unrestricted.
✓. Confirmed diagnosis of MAC pulmonary disease per ATS/IDSA 2020 guidelines or Chinese Guidelines for Diagnosis and Treatment of Nontuberculous Mycobacterial Diseases (2020 edition), with imaging features consistent with nodular bronchiectatic type.
✓. No prior anti-MAC treatment within the 3 months preceding screening.
✓. For premenopausal women of childbearing potential who are not surgically sterile:
✓. Organ function criteria met within one week prior to enrollment:
Exclusion criteria
✕. History of allergy to any study drug in the treatment regimen.
✕. Mixed infections with multiple mycobacteria, bacteria, fungi, or viruses (e.g., HIV coinfection).
✕. Presence of congenital/acquired immunodeficiency disorders, active pulmonary malignancy (primary or metastatic), or other malignancies requiring chemotherapy/radiation therapy during the screening or study period.
✕. Uncontrolled radiation pneumonitis requiring steroid or immunoglobulin pulse therapy, active interstitial lung disease with clinical evidence, uncontrolled and significant pleural effusion or pericardial effusion.
✕. Unstable systemic comorbidities including:
✕. Poor gastrointestinal function or malabsorption syndrome.