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Recruiting Phase 4 NCT07213765

Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease

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Trial Parameters

Condition Mycobacterium Avium Complex Pulmonary Disease
Sponsor Bin Cao
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 188
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-07-24
Completion 2028-09-30
Interventions
ContezolidAzithromycinAzithromycin

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Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. Patients voluntarily participate in this study and sign the Informed Consent Form. 2. Age ≥ 18 years and ≤75 years; gender unrestricted. 3. 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. 4. No prior anti-MAC treatment within the 3 months preceding screening. 5. For premenopausal women of childbearing potential who are not surgically sterile: Must use a medically accepted contraceptive method (e.g., intrauterine device, hormonal contraception, or condom) during the study period and for 3 months following the last dose of investigational treatment. Serum or urine human chorionic gonadotropin (hCG) test must be negative within 72 hours prior to enrollment. Must not be breastfeeding. Male patients with partners of childbearing potential must use effective contraception

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