2025-521493-33-00招募中3 期
Macroleave: Impact of discontinuation of long-term macrolides in stable Non Cystic Fibrosis Bronchiectasis : a multicenter randomized controlled trial
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 185
- 试验地点
- 20
- 主要终点
- The primary efficacy endpoint is the annualized number of PE that have been confirmed through the event adjudication process
研究概览
简要总结
To demonstrate the non-inferiority of withdrawal of low-dose macrolides after at least 1 year of treatment, compared to its continuation, in stable NCFB patients.
研究设计
- 分配方式
- Randomized
- 主要目的
- Continue Macrolide
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age, female or male
- •Diagnosis of bronchiectasis on thoracic CT-scan
- •Treatment with long-term Azithromycin for at least 12 months
- •≤ 1 pulmonary exacerbations in the last 12 months
- •No severe pulmonary exacerbation (with hospitalization due to respiratory failure) in the last 12 months
- •Patient affiliated with the French health care system
- •Able to understand and sign a written informed consent form
排除标准
- •Confirmed diagnosis of cystic fibrosis
- •Lung transplantation
- •Allogenic hematopoietic stem cell transplantation
- •Women of childbearing potential * who do not accept the required contraceptive method below. Combined or progestogen-only hormonal contraception (oral, injectable, implantable, transdermal patch), Intrauterine device (IUD), including copper or hormone-releasing systems, Bilateral tubal occlusion/sterilisation, Complete sexual abstinence, only if it is the participant’s usual and preferred lifestyle and is considered reliable per protocol. * Women are considered not of childbearing potential if they are:Postmenopausal, defined as at least 12 consecutive months of spontaneous amenorrhea without an alternative medical cause, or Permanently sterilized (e.g., documented hysterectomy, bilateral oophorectomy, or bilateral tubal ligation).
- •Male participants with partners of childbearing potential who do not a accept to use appropriate contraception to prevent pregnancy during the study and for the required follow-up period will be excluded from participation; acceptable contraception methods include: - Male condom; - Vasectomy (with documented medical confirmation of surgical success); - True sexual abstinence, only if this is consistent with the participant’s usual and preferred lifestyle; Double-barrier methods (e.g., condom plus diaphragm/cervical cap/spermicide) may be used, although they are not considered highly effective methods.
- •Patients who are relatives of the investigator or any member of the study team directly involved in the conduct of the study (including physicians, pharmacists, nurses, and study coordinators).
- •Patients deprived of liberty by administrative or judicial decision.
- •Patients under legal protection (guardianship or legal supervision).
- •A primary diagnosis of COPD or asthma as judged by the Investigator. Patients with comorbid COPD and/or asthma can be enrolled if bronchiectasis is their primary diagnosis.
- •Pregnancy or breastfeeding
- •Patient participating to another interventional clinical trial
- •Predictable monitoring issues
- •Long-term oxygen therapy and/or noninvasive mechanical ventilation for chronic respiratory insufficiency (except CPAP for OSA) and/or FEV1<30% of predicted value and/or and/or considered for lung transplantation
- •Contraindication to the use of azithromycin: -allergy to macrolides or ketolides - hypersensitivity to any of the excipients - concomitant treatment with QT-interval–prolonging agents; - electrolyte disturbances (hypokalaemia, hypomagnesaemia); - clinically significant bradycardia, cardiac arrhythmia, or severe heart failure; - renal impairment with creatinine clearance < 40 mL/min - - co-administration with alcaloides de l’ergot de seigle (dihydroergotamine, ergotamin), cisapride and ; colchicine - - QTc is >450 ms for men and >470 ms for women - - Severe liver impairment
- •Severe hemoptysis due to a respiratory cause
- •Patient with a solid tumor or hematologic malignancy receiving active (non-maintenance) treatment.
结局指标
主要结局
The primary efficacy endpoint is the annualized number of PE that have been confirmed through the event adjudication process
The primary efficacy endpoint is the annualized number of PE that have been confirmed through the event adjudication process
次要结局
- Time (days) to first exacerbation
- Annual number of severe exacerbations, with hospitalization due to a respiratory failure
- Quality-of-life score (Quality of Life-Bronchiectasis (QOL-B)16 and Bronchiectasis Impact Measure (BIM)) at inclusion, 1 year and 2 years
- Emergence of macrolide-resistant strains of bacteria or mycobacteria, at inclusion, 12 and 24 months
- Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC), at inclusion, 12 and 24 months
- Number of days between randomization and a new prescription of preventive treatment for exacerbations (macrolides, anti-inflammatory such as brenzocatib, long-term antibiotic therapy)
- Prognostic factors for macrolide discontinuation failure (age, severity of the disease, Pseudomonas colonization and duration of macrolides exposition before the beginning of the trial…) will be explored by using uni- and multivariable logistic regression
研究者
Benoit Douvry
Scientific
Centre Hospitalier Intercommunal Creteil
研究点 (20)
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