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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000033996 |
Receipt No. | R000038765 |
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 |
Date of disclosure of the study information | 2018/09/03 |
Last modified on | 2019/03/13 |
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 |
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Condition | ||||
Condition | chronic lower respiratory tract infection | |||
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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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 |
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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 |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
yamasaki@med.uoeh-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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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 |
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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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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. |
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Last modified on |
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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 | |
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Research case data | |
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