An Observational Study on Patients With NTM Pulmonary Disease

July 12, 2020 updated by: LAI PING LO, Chinese University of Hong Kong

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / 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 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.

Study Type

Observational

Enrollment (Anticipated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults suspected NTMPD followed up in the Prince of Wales Hospital will be recruited

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes of NTMPD patients with or without treatment in 1 year
Time Frame: 1 year
Clinical outcomes include stable disease, disease progression, chest infection, death.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical parameters that predict the disease progression
Time Frame: 1 year
Clinical parameters include demographics and comorbidities.
1 year
Functional
Time Frame: 1 year
functional capacity of patients including mobility, exercise tolerance, lung function
1 year
Microbiological parameters that predict disease progression
Time Frame: 1 year
species subtypes, smear positivity and drug resistance
1 year
Radiological features that predict disease progression
Time Frame: 1 year
Pattern and extent of lung involvement
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2020

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

July 3, 2020

First Posted (Actual)

July 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 12, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020.123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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