Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
NCT ID: NCT07213765
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
188 participants
INTERVENTIONAL
2025-07-24
2028-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Contezolid shortened regimen
Contezolid
contezolid 800mg po q12h\*6m
Azithromycin
azithromycin 500mg po tiw (250mg po tiw for BW under 50kg)\*6m
Ethambutol (E)
ethambutol 25mg/kg po tiw\*6m
Rifampicin (R)
rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)\*6m
Standard regimen
Azithromycin
azithromycin 500mg po tiw (250mg po tiw for BW under 50kg)\*12m
Ethambutol (E)
ethambutol 25mg/kg po tiw\*12m
Rifampicin (R)
rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)\*12m
Interventions
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Contezolid
contezolid 800mg po q12h\*6m
Azithromycin
azithromycin 500mg po tiw (250mg po tiw for BW under 50kg)\*6m
Azithromycin
azithromycin 500mg po tiw (250mg po tiw for BW under 50kg)\*12m
Ethambutol (E)
ethambutol 25mg/kg po tiw\*6m
Ethambutol (E)
ethambutol 25mg/kg po tiw\*12m
Rifampicin (R)
rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)\*6m
Rifampicin (R)
rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)\*12m
Eligibility Criteria
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Inclusion Criteria
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 during the study period and for 3 months after the last dose.
6. Organ function criteria met within one week prior to enrollment:
i. Hemoglobin ≥60 g/L; ii. Neutrophil count ≥0.5 × 10⁹/L; iii. Platelet count ≥60 × 10⁹/L; iv. Serum total bilirubin ≤3 × upper limit of normal (ULN); v. Aspartate aminotransferase (AST) ≤3 × ULN; vi. Alanine aminotransferase (ALT) ≤3 × ULN; vii. Serum creatinine \<2 × ULN OR creatinine clearance ≥60 mL/min; viii. Blood urea nitrogen (BUN) ≤200 mg/L; ix. Urinalysis: Proteinuria \<++; if proteinuria is +, 24-hour total protein must be \<500 mg.
x. Fasting blood glucose within normal range OR stable glycemic control in diabetic patients.
xi. Cardiac function: No myocardial infarction in the preceding 6 months; No unstable angina or severe arrhythmias; New York Heart Association (NYHA) functional class \>II.
Exclusion Criteria
2. Mixed infections with multiple mycobacteria, bacteria, fungi, or viruses (e.g., HIV coinfection).
3. 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.
4. History of solid organ transplantation.
5. Currently undergoing dialysis.
6. Uncontrolled radiation pneumonitis requiring steroid or immunoglobulin pulse therapy, active interstitial lung disease with clinical evidence, uncontrolled and significant pleural effusion or pericardial effusion.
7. Unstable systemic comorbidities including:
Hypertensive crisis; Unstable angina; Congestive heart failure (NYHA Class III/IV); Myocardial infarction within the preceding 6 months; Severe psychiatric disorders requiring medication (e.g., schizophrenia, bipolar disorder); Severe hepatic or renal dysfunction (e.g., Child-Pugh Class C cirrhosis, eGFR \<30 mL/min/1.73m²); Neurodegenerative diseases (e.g., Alzheimer's disease).
8. Poor gastrointestinal function or malabsorption syndrome.
9. Receipt of other investigational drugs within 4 weeks prior to the first study drug administration.
10. Concurrent participation in another interventional clinical trial, unless it is an observational/noninterventional study OR follow-up phase of a completed intervention trial.
11. Any physical examination findings or clinical tests deemed by the investigator as likely to:
Interfere with study results; Increase risks of complications during treatment.
18 Years
75 Years
ALL
No
Sponsors
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MicuRx
INDUSTRY
Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Beijing Chest Hospital
OTHER
Anhui Chest Hospital
OTHER
Jiangxi Chest Hospital
UNKNOWN
Guangzhou Chest Hospital.
UNKNOWN
Bin Cao
OTHER
Responsible Party
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Bin Cao
Professor
Principal Investigators
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Xiaojin Cui, M.D.
Role: PRINCIPAL_INVESTIGATOR
China-Japan Friendship Hospital
Locations
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Anhui Chest Hospital
Hefei, Anhui, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Guangzhou Chest Hospital
Guangzhou, Guangdong, China
Jiangxi Chest Hospital
Nanchang, Jiangxi, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Other Identifiers
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2025-KY-004
Identifier Type: -
Identifier Source: org_study_id
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