2024-518578-15-00招募中3 期
CLArithromycin versus AZIthromycin in the treatment of Mycobacterium avium complex pulmonary infections: A randomized prospective controlled study (CLAZI)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 424
- 试验地点
- 50
- 主要终点
- The primary endpoint is the 6-month negative sputum conversion rate.
研究概览
简要总结
To demonstrate the non-inferiority in term of 6-month sputum conversion rate of azithromycin- to clarithromycin-containing regimen in the Mycobacterium avium complex (MAC) lung disease treatment.
研究设计
- 研究类型
- Interventional
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
- •In order to be included, each eligible patient, 18 years old or orlder, must present ATS/IDSA 2007 criteria for nontuberculous mycobacterial pulmonary infection (3). These criteria are as follows: - Clinical criteria o Respiratory symptoms and the presence of nodular or cavitary lesion on chest highresolution computed tomography. Lesions may also present in the form of diffuse micronodular syndrome.
- •AND Microbiological criteria : At least two positive cultures for MAC on two sputum specimens obtained on two different days
- •AND/OR : Positive culture for MAC on bronchoalveolar lavage or bronchoscopic aspiration
- •AND/OR : Transbronchial biopsy or surgical lung biopsy presenting histology in favour of mycobacterial infection (granuloma or positive Ziehl-Neelsen stain) and positive culture for MAC OR biopsy showing histology compatible with mycobacterial infection and one or more sputum cultures positive for MAC
- •AND : Exclusion of other diagnoses on CT scan, bronchoscopy and bacteriological specimens. In the presence of common bacteria, persistence of clinical symptoms and radiological signs after well-conducted antibiotic therapy suggests the diagnosis of MAC infection. The presence of criteria of Aspergillus fumigatus infection associated with the presence of microbiological criteria of MAC infection will lead to the diagnosis of MAC and Aspergillus fumigatus co-infection
排除标准
- •Known hypersensitivity to one of the molecules of the study (rifampin, ethambutol, azithromycin, clarithromycin)
- •Limited life expectancy (e.g 6 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%
- •Patient already participating in a clinical trial of a treatment or a therapeutic strategy for non-mycobacterial Tubercular
- •Relapse of MAC lung infection
- •Macrolide resistant strain, based on genotyping susceptibility testing (must be done before inclusion)
- •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
- •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
The primary endpoint is the 6-month negative sputum conversion rate.
The primary endpoint is the 6-month negative sputum conversion rate.
次要结局
- For safety: digestive toxicity (WHO criteria and Rhodes scale (28, 29)), for hepatitis (cytolysis higher than 3 times normal rate)
- Clinical improvement on analogic scales
- Radiological improvement on CT scan criteria (dimensions of the lesions compared to the baseline CT, classified as complete resolution of the lesions, partial resolution of the lesions: reduction of at least 50% of the lesions, stabilization: size of the lesion between 50% and 130% compared to baseline, deterioration of lesions: appearance of new lesions or greater than 30%
- 3 and 12 months sputum conversion (Culture results of respiratory specimens taken 3 and 12 months after starting treatment)
- 12 months outcome (death)
- 1 month and 6 months peak serum and mononuclear cells concentration of azithromycin and clarithromycin and their main metabolites (D-azithromycin and 14-OH clarithromycin respectively) determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS)
- MAC species and 6-month conversion
研究者
Claire ANDRJEAK
Scientific
Centre Hospitalier Universitaire Amiens Picardie
研究点 (50)
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