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An Observational Study on Patients With NTM Pulmonary Disease

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04463134
Collaborator
(none)
50
Enrollment
35.9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: NTM drug treatment

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

  1. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Observational Study of Parameters Related to the Clinical Outcomes of NTM Pulmonary Disease in Prince of Wales Hospital
Anticipated Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Treatment group

They will start pharmacological treatment according to guidelines and sensitivity

Drug: NTM drug treatment
NTM drug treatment according to guideline and sensitivity test results
Other Names:
  • pharmacological treatment

    		•
    Observation group

    They will not start pharmacological treatment. They will be monitored on symptoms, sputum conversion and radiological progression

    Outcome Measures

    Primary Outcome Measures

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

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

    Secondary Outcome Measures

    1. Clinical parameters that predict the disease progression [1 year]

      Clinical parameters include demographics and comorbidities.

    2. Functional [1 year]

      functional capacity of patients including mobility, exercise tolerance, lung function

    3. Microbiological parameters that predict disease progression [1 year]

      species subtypes, smear positivity and drug resistance

    4. Radiological features that predict disease progression [1 year]

      Pattern and extent of lung involvement

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    LAI PING LO, Resident, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT04463134
    Other Study ID Numbers:
    • 2020.123
    First Posted:
    Jul 9, 2020
    Last Update Posted:
    Jul 14, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by LAI PING LO, Resident, Chinese University of Hong Kong
    Disease progression, death
    Additional relevant MeSH terms:
    Lung Diseases

    Study Results

    No Results Posted as of Jul 14, 2020