Efficacy of Clarithromycin or Moxifloxacin Containing Regimen in 6 Months Sputum Conversion of Mycobacterium Xenopi
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 52
- 主要终点
- Sputum conversion at 6 months under three antibiotics treatment (Rifampin, ethambutol and a third drug clarithromycin or moxifloxacin)
研究概览
简要总结
The purpose of this study is to determine the 6-months sputum conversion rate with a clarithromycin or moxifloxacin containing regimen in patients with a M. xenopi pulmonary infection.
详细描述
In France, Mycobacterium xenopi is the second non-tuberculous mycobacteria responsible of pulmonary infections. There are few data in the literature regarding its treatment apart from two small randomized trials (42 and 34 patients, respectively) and a French retrospective study (136 patients). So, we decided to conduct a prospective randomized multicenter study to evaluate two treatment regimens for Mycobacterium xenopi pulmonary infection in 6-months sputum conversion.
Main objective: To determine the 6-months sputum conversion rate with a clarithromycin or moxifloxacin containing regimen in patients with M.xenopi pulmonary infections according to ATS / IDSA 2007 criteria.
Secondary Objectives: To compare the rate of sputum conversion after 3 and 6 months of treatment the clinical and radiological outcome and the 12 months mortality.
primary endpoint : Result of culture of respiratory samples 6 months after starting treatment.Culture samples taken 6 months after starting treatment against M. xenopi is either positive (presence of M. xenopi colonies with or without smear positive) or negative with smear and culture negative (see data collection and measurement methods).
Study plan: Any patient with at least one positive pulmonary M. xenopi sample may be eligible. If the patient underwent ATS / IDSA 2007 criteria of M. xenopi pulmonary infection (after clinical , radiological and microbiological evaluation), in the absence of exclusion criteria, the patient will be randomized to one of the two treatment arms (rifampicin+ ethambutol + clarithromycin or rifampicin + ethambutol + moxifloxacin). A clinical, radiological, microbiological and pharmacological monitoring will be done for each randomized patient. The recommended treatment duration is 12 months after conversion with a maximum duration of 18 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient and/or legal representative of the patient has provided a written informed consent before inclusion in the study
- •The patient is aged 18 or older
- •The patient has signs of functional respiratory (cough, sputum, hemoptysis, dyspnea, chest pain and / or general signs (asthenia and / or anorexia and / or weight loss)
- •The patient has a creatinine clearance above 30 ml / min
- •The patient underwent a thoracic scan not older than one month before the first positive bacteriological sample.
- •The patient underwent a bronchoscopy with sampling conducted in the territory corresponding to the radiographic
- •The most plausible alternative diagnostics have been eliminated using the thoracic scan and bronchoscopy
- •The patient has at least two positive cultures for M. xenopi sputum collected on two separate days AND/OR a positive culture for M. xenopi in a bronchoalveolar lavage or bronchial aspiration directed AND / OR transbronchial biopsy or lung biopsy with surgical histology for a mycobacterial infection (granuloma or Ziehl positive) and a culture positive M. xenopi, AND / OR biopsy with histology compatible with mycobacteriosis and one or more positive sputum culture for M . xenopi
- •The patient is willing and able to take the study treatment throughout the duration
- •If this is a woman of childbearing age, the patient is ready to use for the duration of the test contraception method other than estrogen-progestin
- •The patient did not participate in another study evaluating an investigational drug within 30 days prior to enrollment in the study and agrees not to participate in another study for the duration of the study
- •The patient is informed by the doctor and agreed that its data are processed in this study
- •The patient understands / reads French and has no difficulty understanding the objectives of the study
- •The patient has health insurance coverage
排除标准
- •Hypersensitivity to any of the molecules (rifampicin, ethambutol, moxifloxacin, clarithromycin)
- •Any patient with a relapse of a lung infection with M. xenopi
- •The patient is treated with molecules that can interfere with cytochrome P450 and can not be replaced by another therapeutic class
- •The patient is treated by prolonging the QT molecules which can not be replaced by another therapeutic class
- •The patient is treated with alkaloid of ergot, cisapride, biperidil, pimozide, mizolastine
- •The patient has heart failure with left ventricular ejection fraction below 30%
- •Discovered on the balance sheet or history, we find that the patient infection with human immunodeficiency virus HIV 1 and 2 a long QT on ECG and / or arrhythmias or clinically significant bradycardia judged by the investigator cytolysis with transaminases increase more than 5 times normal renal failure with creatinine clearance below 30 ml / min
- •The patient has cirrhosis Child Pugh C and / or porphyria
- •There pregnancy or during breastfeeding
- •The patient has an inability to meet the protocol requirements, including active substance abuse, according to the investigator.
- •The patient has a history of tendinopathy with a fluoroquinolone
- •The patient has a congenital galactosemia, malabsorption of glucose and galactose, or lactase deficiency
- •The patient has a NORB (abnormalities of the visual field or color vision tested by an eye examination prior)
- •Any other situation that, in the opinion of the investigator, would imply that participation in the study is not in the interest of the patient
- •There is a risk of difficulty of monitoring, such as imminent transfer to a different region or country
研究组 & 干预措施
Moxifloxacin
干预措施: Moxifloxacin (Drug)
Clarithromycin
干预措施: Clarithromycin (Drug)
结局指标
主要结局
Sputum conversion at 6 months under three antibiotics treatment (Rifampin, ethambutol and a third drug clarithromycin or moxifloxacin)
时间窗: 6 months
Results of the smear and culture of three respiratory samples after 6 months of treatment.
次要结局
- Sputum conversion at 3, 6, 9 and 12 months of treatment in the two different arms (clarithromycin containing regimen versus moxifloxacin containing regimen(12 months)
- Clinical and radiological outcome after 3, 6 and 12 months of treatment according to the treatment arm(12 months)
- Mortality after 12 months of treatment in the two compared regimen(12 months)
- Gastrointestinal toxicity and hematotoxicity after 1- 3- 6- 9- 12- months of treatment(12 months)