UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000028078
Receipt No. R000032146
Scientific Title Evaluation of the microbiota in pleural effusion obtained from patients with bacterial pleurisy and the relationship between clinical features and causative pathogens in patients with bacterial pleurisy using a clone library method
Date of disclosure of the study information 2017/07/07
Last modified on 2018/07/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of the microbiota in pleural effusion obtained from patients with bacterial pleurisy and the relationship between clinical features and causative pathogens in patients with bacterial pleurisy using a clone library method
Acronym Evaluation of the microbiota in pleural effusion obtained from patients with bacterial pleurisy and the relationship between clinical features and causative pathogens in patients with bacterial pleurisy using a clone library method
Scientific Title Evaluation of the microbiota in pleural effusion obtained from patients with bacterial pleurisy and the relationship between clinical features and causative pathogens in patients with bacterial pleurisy using a clone library method
Scientific Title:Acronym Evaluation of the microbiota in pleural effusion obtained from patients with bacterial pleurisy and the relationship between clinical features and causative pathogens in patients with bacterial pleurisy using a clone library method
Region
Japan

Condition
Condition bacterial pleurisy
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the microbiota in pleural effusion obtained from patients with bacterial pleurisy and the relationship between clinical features and causative pathogens in patients with bacterial pleurisy using a clone library method
Basic objectives2 Others
Basic objectives -Others Epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The differences between clinical features and each pathogen detected by using a clone library method in patients with bacterial pleurisy
Key secondary outcomes Comparison of pathogens detected by a clone library method and cultivation methods

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 1. Patients with 20 years of age and older
2. Patients who had exudative pleural effusion with predominance of neutrophils
3. Patients (or their legal acceptable representative) who provided written informed consent
Key exclusion criteria 1. Patients who were not bacterial pleurisy and strongly suspected to have other underlying disease
2. Patients deemed ineligible by the attending physicians for various reasons
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinori Kawanami
Organization University of Occupational and Environmental Health, japan
Division name Department of Respiratory MedicineDepartment of Respiratory Medicine
Zip code
Address 1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
TEL 093-603-1611
Email namihei@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryosuke Hata
Organization University of Occupational and Environmental Health, japan
Division name Department of Respiratory MedicineDepartment of Respiratory Medicine
Zip code
Address 1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
TEL 093-603-1611
Homepage URL
Email hata_kn@yahoo.co.jp

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

Funding Source
Organization Department of Respiratory Medicine,University of Occupational and Environmental Health, japan
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
Address
Tel
Email

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
2017 Year 07 Month 07 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
Due to poor collection of cases of target disease, accumulation of the target number of cases is difficult, furthermore, results can not be expected from the results of intermediate analysis, it was judged to be canceled. There were no problems such as adverse events.
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 Terminated
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is prospective observational study.

Management information
Registered date
2017 Year 07 Month 05 Day
Last modified on
2018 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032146

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.