2023-506843-40-00招募中3 期
AKAPI: Amikacin Liposome Inhalation Suspension for treatment of Mycobacterium xenopi pulmonary infection: A prospective controlled open-label randomized study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 33
- 主要终点
- 3 months sputum conversion rate
研究概览
简要总结
to demonstrate the superiority of ARIKAYCE addition to a standard treatment in term of 3-month sputum conversion rate compared to standard regimen alone in M. xenopi pulmonary infection (MX-PD).
研究设计
- 分配方式
- Randomized
- 主要目的
- Two treatment regimens containing three molecules with or without ARIKAYCE.
- 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 old or older, must present 2020 ATS/ERS/ESCMID/IDSA criteria for nontuberculous mycobacterial pulmonary infection
- •Clinical criteria Respiratory symptoms and the presence of nodular or cavitary lesion on chest x-ray, confirmed on chest high-resolution computed tomography. Lesions may also present in the form of diffuse micronodular syndrome.
- •Microbiological criteria: o At least two positive cultures for MX on two sputum specimens obtained on two different days, at least separate of 7 days AND/OR o Positive culture for MX on bronchoalveolar lavage or bronchoscopic aspiration AND/OR o Transbronchial biopsy or surgical lung biopsy presenting histology in favour of mycobacterial infection (granuloma or positive Ziehl-Neelsen stain) and positive culture for MX OR biopsy showing histology compatible with mycobacterial infection and one or more sputum cultures positive for MX
- •Exclusion of other diagnoses on CT scan, bronchoscopy and bacteriological specimens.
排除标准
- •Known hypersensitivity to one of the molecules of the study
- •Limited life expectancy (e.g 36 months)
- •Patients with hematologic malignancies and allogeneic haematopoietic stem cells
- •Women of childbearing age and not using an effective method of contraception (Pearl Index <1%)
- •The patient is treated with molecules prolonging the QT interval that cannot be replaced by another therapeutic class.
- •The patient presents a heart failure with left ventricular ejection fraction less than 30%.
- •Relapse of MX lung infection
- •Treatment with molecules able to interfere with cytochrome P450 that cannot be replaced by another therapeutic class
- •HIV 1 and 2 human immunodeficiency virus infection
- •Renal failure with creatinine clearance less than 30 mL/min
- •Pregnancy and breastfeeding
- •Cystic fibrosis
- •Contraindications to one of the antibiotic
- •Inability to comply with the requirements of the protocol, especially substance abuse, according to the investigator.
结局指标
主要结局
3 months sputum conversion rate
3 months sputum conversion rate
次要结局
- 6 months sputum conversion rate, recurrence, failure, relapse, cure, death and safety
研究者
ROUSSEAUX Justine
Scientific
Centre Hospitalier Universitaire Amiens Picardie
研究点 (33)
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