Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease

Обзор

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.

Вмешательства

• Препарат Contezolid
  contezolid 800mg po q12h\*6m
• Препарат Azithromycin
  azithromycin 500mg po tiw (250mg po tiw for BW under 50kg)\*6m
• Препарат Azithromycin
  azithromycin 500mg po tiw (250mg po tiw for BW under 50kg)\*12m
• Препарат Ethambutol (E)
  ethambutol 25mg/kg po tiw\*6m
• Препарат Ethambutol (E)
  ethambutol 25mg/kg po tiw\*12m
• Препарат Rifampicin (R)
  rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)\*6m
• Препарат Rifampicin (R)
  rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)\*12m

Первичные конечные точки

• culture conversion [Срок оценки: end of month 6]
• CT lesion absorption [Срок оценки: end of month 6]
• QOL-B+NTM module [Срок оценки: end of month 6]

Вторичные конечные точки (5)

• culture conversion [Срок оценки: up to month 12]
• CT lesion status [Срок оценки: end of month 3, 6, and 12 (for standard regimen)/end of month 3 and 6 (for shortened regimen)]
• Questionnaire: Quality of life-bronchiectasis (QOL-B) and NTM module [Срок оценки: up to month 12]
• SGRQ [Срок оценки: up to month 12]
• time to positivity of mycobacterium culture [Срок оценки: up to month 12]

Критерии участия

Критерии включения

• 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:

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.

Критерии исключения

• 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.
• Currently undergoing dialysis.
• 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:

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).

• Poor gastrointestinal function or malabsorption syndrome.
• 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.
• Any physical examination findings or clinical tests deemed by the investigator as likely to:

Interfere with study results; Increase risks of complications during treatment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 6 центров

• Anhui Chest Hospital — Хэфэй
• Beijing Chest Hospital, Capital Medical University — Пекин
• China-Japan Friendship Hospital — Пекин
• Guangzhou Chest Hospital — Гуанчжоу
• Jiangxi Chest Hospital — Nanchang
• Shanghai Pulmonary Hospital — Шанхай

Идентификаторы

NCT: NCT07213765 · 2025-KY-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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