A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 15
- 主要终点
- Culture conversion rate
研究概览
简要总结
To gain insight in the effectiveness of, adherence and adjustments to guideline-based three-drug antimycobacterial therapy in patients with Mycobacterium avium complex pulmonary disease (MAC-PD) during the first 6 months of treatment.
详细描述
Mycobacterium avium complex (MAC) is the most frequent causative species that results in nontuberculous mycobacterial pulmonary disease (NTM-PD). Current treatment outcomes for MAC-PD are unsatisfactory with sputum culture conversion rates between 50-70%.The high prevalence of drug toxicity and low adherence to guideline-based treatment (GBT) are key reasons for the limited treatment success. Hence, there is an unmet need for prospective data on effectiveness of, adherence and adjustments to MAC-PD treatment regimens. By collaborating with NTM-NET and ESGMYC affiliated medical centers, we enable systematic, prospective data collection of an international MAC-PD cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Newly diagnosed MAC-PD (primary or recurrent) as per the international NTM guideline that requires three-drug antimycobacterial treatment
- •Signed and dated informed consent
排除标准
- •The participant is in poor general condition where participation in the study cannot be accepted per discretion of the Investigator
- •The participant has a known or suspected, current drug or alcohol abuse, that is, in the opinion of the Investigator, sufficient to compromise the safety or cooperation of the patient
- •HIV-infection;
- •Cystic fibrosis;
- •>1 month antibiotic treatment for current MAC infection;
- •< 6 months between previous antimycobacterial NTM-PD treatment and antimycobacterial treatment for current MAC-PD
- •Disseminated MAC infection;
- •Active pulmonary tuberculosis, fungal or nocardial disease requiring treatment;
- •Active pulmonary malignancy (primary or metastatic) or any other malignancy requiring chemotherapy or radiotherapy within 6 months before screening or anticipated during the study period;
结局指标
主要结局
Culture conversion rate
时间窗: 6 months
Conversion from positive cultures at baseline to negative cultures after 6 months of antimycobacterial treatment, defined by three or more negative sputum cultures sampled a month apart or one negative culture from a bronchial lavage.
次要结局
- Adverse drug reactions to antimycobacterial treatment(6 months)
- Other treatment adjustments(6 months)
- Change in symptoms compared to baseline(6 months)
- Antimycobacterial treatment adjustments(6 months)
- Change in mycobacterial load compared to baseline(6 months)