Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT07084402
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 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:
1. History of allergy to any study drug in the treatment regimen.
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07084402
Study Brief:
Protocol Section:
NCT07084402