Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease

Korábbi kezelés

• Receipt of other investigational drugs within 4 weeks prior to the first study drug administration.
• Concurrent participation in another interventional clinical trial, unless it is an observational/noninterventional study OR follow-up phase of a completed intervention trial.

Más betegség

• 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.
• History of solid organ transplantation.
• Uncontrolled radiation pneumonitis requiring steroid or immunoglobulin pulse therapy, active interstitial lung disease with clinical evidence, uncontrolled and significant pleural effusion or pericardial effusion.
• Poor gastrointestinal function or malabsorption syndrome.

Laborértékek

• 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).

Egyéb

• Currently undergoing dialysis.
• Any physical examination findings or clinical tests deemed by the investigator as likely to:
  • Interfere with study results; Increase risks of complications during treatment.

• 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:
  • 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.
• Organ function criteria met within one week prior to enrollment:
• 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.
• Fasting blood glucose within normal range OR stable glycemic control in diabetic patients.
• Cardiac function: No myocardial infarction in the preceding 6 months; No unstable angina or severe arrhythmias; New York Heart Association (NYHA) functional class \>II.