Short-term Bactericidal Effect of Contezolid in MAC-PD (NCT07084402) | Clinical Trial Compass
RecruitingPhase 4
Short-term Bactericidal Effect of Contezolid in MAC-PD
China188 participantsStarted 2025-07-24
Plain-language summary
The goal of this clinical trial is to learn if contezolid works to treat mycobacterium avium complex pulmonary disease in adults. It will also learn about the safety of contezolid. The main questions it aims to answer are:
Does adding contezolid to standard regimen further decrease the bacterial load in patients' sputum compared with current standard regimen? What medical problems do participants have when taking contezolid along with standard regimen? Researchers will compare standard regimen plus contezolid to standard regimen alone to see if contezolid helps further lower the count of bacteria in patients' sputum.
Participants will:
Take contezolid and standard regimen (azithromycin, ethambutol and rifampicin) or standard regimen only for 6 months, contezolid is administered every day while other drugs are taken 3 times a week 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.
What they're measuring
1
time-to-positivity of sputum mycobacterium culture
✕. 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.