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An Observational Study on Patients With NTM Pulmonary Disease

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04463134
Enrollment
50
Registered
2020-07-09
Start date
2020-08-01
Completion date
2023-07-31
Last updated
2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Outcomes

Keywords

Disease progression, death

Brief summary

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.

Detailed description

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.

Interventions

DRUGNTM drug treatment

NTM drug treatment according to guideline and sensitivity test results

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical outcomes of NTMPD patients with or without treatment in 1 year1 yearClinical outcomes include stable disease, disease progression, chest infection, death.

Secondary

MeasureTime frameDescription
Clinical parameters that predict the disease progression1 yearClinical parameters include demographics and comorbidities.
Functional1 yearfunctional capacity of patients including mobility, exercise tolerance, lung function
Microbiological parameters that predict disease progression1 yearspecies subtypes, smear positivity and drug resistance
Radiological features that predict disease progression1 yearPattern and extent of lung involvement

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026