UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000028078
Receipt number	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 17:01:26

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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

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

bacterial pleurisy

Classification by specialty

Pneumology Infectious disease

Classification by malignancy

Others

Genomic information

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

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 or person

Institute

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

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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