Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 188
- 试验地点
- 6
- 主要终点
- culture conversion
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Contezolid shortened regimen
干预措施: Contezolid (Drug)
Contezolid shortened regimen
干预措施: Azithromycin (Drug)
Contezolid shortened regimen
干预措施: Ethambutol (E) (Drug)
Contezolid shortened regimen
干预措施: Rifampicin (R) (Drug)
Standard regimen
干预措施: Azithromycin (Drug)
Standard regimen
干预措施: Ethambutol (E) (Drug)
Standard regimen
干预措施: Rifampicin (R) (Drug)
结局指标
主要结局
culture conversion
时间窗: end of month 6
2 consecutive negative sputum mycobacterial culture at least 4 weeks apart, or one negative bronchoalveolar lavage fluid culture/NGS.
CT lesion absorption
时间窗: end of month 6
\>30% decrease in lesion size or number of nodules measured on CT
QOL-B+NTM module
时间窗: end of month 6
Improvement greater than MID in at least 7 out of 12 domains in QOL-B with NTM-module (must include respiratory symptoms and NTM-PD symptoms)
次要结局
- culture conversion(up to month 12)
- CT lesion status(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(up to month 12)
- SGRQ(up to month 12)
- time to positivity of mycobacterium culture(up to month 12)
研究者
Bin Cao
Professor
Capital Medical University