UMIN-CTR Clinical Trial

Basic information
Public title	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
Acronym	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
Scientific Title	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
Scientific Title:Acronym	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
Region	Japan

Condition
Condition	chronic lower respiratory tract infection
Classification by specialty	Medicine in general Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the role of bacterial flora that are detected by cultivation-independent molecular biological modalities using bronchoalveolar lavage fluid (BALF). BALF specimens were directly obtained from lung lesion of patient with chronic lower respiratory tract infection or pulmonary nontuberculous mycobacteriosis(NTM). In addition, we use flow cytometry to isolate the alveolar macrophages from the BALF and quantify the phagocytic ability of macrophages against bacteria and fungi. We then simultaneously compare the results of the flow cytometry, a bacterial flora analysis, imaging findings of the airway/lung lesions of patients with pulmonary NTM, timing of illness progression, prognosis, disease duration and the relationship with antibiotic therapy. Based on the results of this study, our goal is to establish new therapeutic strategies such as the use of antimycotics and antifungal drugs from the early stage of this disease.
Basic objectives2	Others
Basic objectives -Others	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.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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.
Key secondary outcomes	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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Yamasaki
Organization	University of Occupational and Environmental Health, Japan
Division name	Department of Respiratory Medicine
Zip code	807-8555
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu city, Fukuoka, 807-8555, Japan
TEL	093-691-7453
Email	yamasaki@med.uoeh-u.ac.jp

Public contact
Name of contact person	1st name Hiroaki Middle name Last name Ikegami
Organization	University of Occupational and Environmental Health, Japan
Division name	Department of Respiratory Medicine
Zip code	807-8555
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu city, Fukuoka, 807-8555, Japan
TEL	093-691-7453
Homepage URL
Email	h_i214538y@yahoo.co.jp

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

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Medical Research,University of Occupational and Environmental Health,Japan
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu city, Fukuoka, 807-8555, Japan
Tel	093-691-7205
Email	daigakukanri@mbox.pub.uoeh-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 08 Month 01 Day
Date of IRB	2018 Year 10 Month 10 Day
Anticipated trial start date	2018 Year 10 Month 11 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This clinical trial is a prospective observational study. Patients who meet selection criteria and do not conflict with exclusion criteria are included. This study is scheduled to end in June 2021.

Management information
Registered date	2018 Year 09 Month 02 Day
Last modified on	2019 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038765

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
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