Elucidation of the pathogenesis of chronic lower respiratory tract infection focusing on the phagocytic ability of lung macrophage phenotypes and the bacterial flora of the lower airway

Elucidation of the pathogenesis of chronic lower respiratory tract infection focusing on the phagocytic ability of lung macrophage phenotypes and the bacterial flora of the lower airway - Elucidation of the pathogenesis of chronic lower respiratory tract infection focusing on the phagocytic ability of lung macrophage phenotypes and the bacterial flora of the lower airway

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033996

Enrollment

Registered

2018-09-03

Start date

2018-10-11

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

chronic lower respiratory tract infection

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with suspected chronic lower respiratory tract infection (including pulmonary NTM disease) and who meet the following selection criteria and do not conflict with the exclusion criteria are registered. We use the microbiological criteria for the American Thoracic Society/Infectious Disease Society of America definition of NTM with a few modifications. A diagnosis of NTM required the fulfilment of the following radiographic criteria and at least one of the following microbiologic criteria. A. Radiographic criteria 1. Chest imaging findings showing either nodular shadow, small nodular shadow, branched shadow, uniformity shadow, cavity opacities, or multifocal bronchiectasis findings 2. Exclusion of other diagnoses B. Microbiologic criteria 1. Positive culture results for at least two separate expectorated sputum samples 2. Positive culture results for one bronchial wash/lavage sample 3. Positive findings on a transbronchial or other lung biopsy with histopathological features of mycobacteria, and one or more sputum or bronchial washing cultures positive for NTM

Exclusion criteria

Exclusion criteria: The following patients are excluded. 1. Patients who do not agree with this study 2. Patients for whom bronchoscopy is difficult to preform because of comorbidity and who do not agree with bronchoscopy

Design outcomes

Primary

Measure	Time frame
We compare patients with and without pulmonary NTM disease and evaluate the statistically significant differences in the results of the bacterial flora analysis, the differentiation ability according to the macrophages phenotypes (proportion of macrophages phenotype), and the CT findings.	—

Secondary

Measure	Time frame
We evaluate the following problems at the start of the test and 24 to 28 weeks after this trial started. 1) Clinical manifestations, laboratory findings 2) Microbiological evaluation: Transition of causative bacteria with sputum 3) Cytokines, oxidative stress markers in BALF (including TNF-a, NOS, HO-1, IL-4, IL-6, IL-8, IL-13 and others). 4) The time-dependent change of the CT findings	—

Countries

Japan

Contacts

Public ContactHiroaki Ikegami

University of Occupational and Environmental Health, Japan Department of Respiratory Medicine

h_i214538y@yahoo.co.jp093-691-7453

Outcome results