UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033996 |
|---|---|
| Receipt number | 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 | 2022/09/16 10:29:50 |
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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
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
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
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
h_i214538y@yahoo.co.jp
Sponsor or person
Institute
Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
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
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
https://www.sciencedirect.com/science/article/pii/S1341321X22002148?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1341321X22002148?via%3Dihub
Number of participants that the trial has enrolled
30
Results
This study revealed that AMs of the patients with NTM infection accounted for a higher rate of non-polarized (HLA-DR+CD40-CD163-) macrophage than that in the controls. In addition, AMs in the NTM group had an impaired ability to phagocytose S. aureus. In vitro experiments revealed increased intracellular S. aureus counts in M. intracellulare-infected macrophages compared with those in non-NTM-infected macrophages.
Results date posted
| 2022 | Year | 09 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
11 NTM-infected and 19 non-NTM-infected patients participated in the study. There were no patients with COPD in either group. Among the patients with NTM infection, the detected NTM were M. avium (n = 6) and M. intracellulare (n = 5). There were no significant differences in clinical characteristics between NTM- and non-NTM-infected patients.
Participant flow
The clinical data collected from the participants included age, gender, comorbid diseases, and medications. Then, they underwent bronchoscopy for diagnostic purposes of pulmonary NTM disease.
Adverse events
There were no adverse events associated with bronchoscopy.
Outcome measures
BALF was evaluated to differentiate AM phenotypes (CD40: M1 marker, CD163: M2 marker, MHC class II: macrophage marker), and their phagocytosis was examined. In vitro study, macrophage cell lines infected with Mycobacterium intracellulare were co-infected with Staphylococcus aureus to evaluate the bactericidal ability.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038765
