EUCTR2015-003786-28-NL进行中（未招募）1 期
Pulmonary NTM disease: A regimen of ethambutol and azithromycin with as adjunctive rifampicin vs clofazimine. - PERC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Radboudumc
- 入组人数
- 123
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- ATS diagnostic criteria for fibro-cavitary MAC-PD met, i.e. symptomatic, fibro-cavitary lesions seen on X-ray or (HR)CT scan of the lungs and =2 positive cultures of the same M. avium complex species (Griffith et al., 2007).
- •- At least one of the positive cultures must be done in the last 4 months before inclusion.
- •- Age > 18 years.
- •- Signed and dated patient informed consent.
- •- Patients can be included in spite of previous treatment if treatment was conform ATS-guidelines and they did not receive any treatment in the last 2 months.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 62
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 62
排除标准
- •- Extensive cavitary MAC-PD defined as cavitary lesions in two or more lobes with the smallest cavity having a diameter >3 centimetre, measured from Computed Tomography (CT) images or when physician deems it favourable to treat the patient with additional amikacine
- •- Macrolide-resistant MAC strain isolated at the time of diagnosis.
- •- A relevant medical history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- •- Use of concomitant drugs that interfere with the pharmacokinetics of the study drugs.
- •- HIV infected.
- •- Diagnosed with cystic fibrosis.
- •- Pregnant or breastfeeding or inadequate contraceptive measures (if applicable).
- •- ALAT > 3 times the upper limit of normal.
- •- ASAT > 3 times the upper limit of normal.
- •- An abnormal serum creatinine level (defined as a level that is higher than the upper limit of normal).
- •- Active pulmonary malignancy (primary or metastatic) or any other malignancy requiring chemotherapy or radiotherapy within 1 year before screening or anticipated during the study period.
- •- Use of drugs for co-morbid conditions that have interactions with any of the drugs in the study and that cannot be safely exchanged for an alternative drug for which such interactions are not known to occur.
- •- Active alcohol abuse.
- •- Hypersensitivity to one of the study drugs.
- •- Patients with previous failure of treatment for MAC-PD, defined as persistent culture positivity despite >6 months of guideline-recommended treatment.
- •- Patients who need to stop treatment for more then 15 consecutive days
研究者
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