An Observational Study on Patients With NTM Pulmonary Disease

NCT04463134 | Unknown

• 1 other identifier: 2020.123
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Clinical Outcomes

Keywords

Disease progression, death

Outcome Measures

Primary Outcomes (1)

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

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

  1 year

Secondary Outcomes (4)

• Clinical parameters that predict the disease progression

  1 year

• Functional

  1 year

• Microbiological parameters that predict disease progression

  1 year

• Radiological features that predict disease progression

  1 year

Study Arms (2)

Treatment group

They will start pharmacological treatment according to guidelines and sensitivity

Drug: NTM drug treatment

Observation group

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

Interventions

NTM drug treatment DRUG

NTM drug treatment according to guideline and sensitivity test results

Also known as: pharmacological treatment

Treatment group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Related Publications (23)

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MeSH Terms

Conditions

Disease Progression; Death

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 9, 2020
• Study Start: August 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2023
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share