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临床试验/NCT04463134
NCT04463134Unknown不适用

A Prospective Observational Study of Parameters Related to the Clinical Outcomes of NTM Pulmonary Disease in Prince of Wales Hospital

Chinese University of Hong Kong0 个研究点目标入组 50 人开始时间: 2020年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
50
主要终点
Clinical outcomes of NTMPD patients with or without treatment in 1 year

研究概览

简要总结

Non-tuberculous mycobacterial (NTM) infection is becoming more and more common, especially causing pulmonary diseases in those elderly or the immunocompromised. The diagnosis, treatment and monitoring of NTM pulmonary disease(NTMPD) are not updated and real life management if also challenging.

详细描述

Non-tuberculous mycobacteria (NTM) are a large group of ubiquitous microorganisms in the natural environment as well as household water systems . Over 180 different species have been identified but only 32 are reported to cause diseases in human or animals. NTM infection can affect the lung, skin and soft tissue, lymph node or cause disseminated diseases in the immunocompromised. NTM pulmonary diseases are the most important disease entity, accounting for 75-94% of all clinically important NTM cases.

The predominant species and their pathogenicity vary in different countries. While Mycobacterium avium-intracellulare complex (MAC) is most prevalent in the USA, Canada, Australia, Japan, Taiwan and Hong Kong, M. abscessus complex is more common in Singapore and M. Kansasii in European counties, respectively. Recently reports showed an increasing trend in importance of NTM PD in a few countries.

NTM can cause chronic and debilitating pulmonary disease with increased morbidity and even mortality. Healthy individuals can be affected though many have underlying structural lung diseases or immunodeficient conditions. Patients usually present with nonspecific symptoms, including productive cough, dyspnea, hemoptysis, fever, weight loss and malaise. Therefore, the diagnosis of NTM pulmonary disease (NTMPD) is challenging requiring comprehensive clinical, microbiological and radiological data according to in the American Thoracic Society and Infectious Diseases Society of America (ATS/IDSA) 2007 guidelines. Treatment of NTMPD is also a difficult decision because some remain stable for a long period without treatment while the others progress to severe and even fatal diseases. A prolonged course of antibiotic involving multiple agents with potential adverse effects is needed but a cure cannot be guaranteed. Moreover, the treatment regimens might be different from those recommended by the international guidelines after balancing multiple factors, including patients' comorbidities, disease severity, and the species and antimicrobial susceptibility of the causative organism. Therefore, whom to treat, when to start and how to treat is a clinical dilemma. Epidemiological data of NTM remains unclear although an increase in prevalence and incidence are consistently observed globally. It is not a notifiable disease in most of the countries and data mainly comes from sentinel surveillance and microbiological results.

Local epidemiological data of NTM infection in Hong Kong is largely scarce apart from a small study done 25 years ago in 1995. Further local investigation on the epidemiology, disease course and clinical practice is needed to optimize their management.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 or above
  • Two or more respiratory samples positive for NTM, including sputum, tracheal aspirates, bronchial washing, bronchial aspirates, bronchial trap and bronchoalveolar lavage or lung biopsy

排除标准

  • NTM isolates from extrapulmonary samples
  • Refused to sign an informed consent

研究组 & 干预措施

Treatment group

They will start pharmacological treatment according to guidelines and sensitivity

干预措施: NTM drug treatment (Drug)

结局指标

主要结局

Clinical outcomes of NTMPD patients with or without treatment in 1 year

时间窗: 1 year

Clinical outcomes include stable disease, disease progression, chest infection, death.

次要结局

  • Functional(1 year)
  • Microbiological parameters that predict disease progression(1 year)
  • Radiological features that predict disease progression(1 year)
  • Clinical parameters that predict the disease progression(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

LAI PING LO

Resident

Chinese University of Hong Kong

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