UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041132 |
|---|---|
| Receipt number | R000046970 |
| Scientific Title | Evaluation of the usefulness of a transport container for anaerobic bacteria (Kenki-porter II) to identify causative pathogens of patients with suspected bacterial pleuritis or empyema |
| Date of disclosure of the study information | 2020/07/20 |
| Last modified on | 2023/02/08 11:43:50 |
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Basic information
Public title
Evaluation of the usefulness of a transport container for anaerobic bacteria (Kenki-porter II) to identify causative pathogens of patients with suspected bacterial pleuritis or empyema
Acronym
Usefulness of a transport container for anaerobic bacteria (Kenki-porter II) for patients with suspected empyema
Scientific Title
Evaluation of the usefulness of a transport container for anaerobic bacteria (Kenki-porter II) to identify causative pathogens of patients with suspected bacterial pleuritis or empyema
Scientific Title:Acronym
Usefulness of a transport container for anaerobic bacteria (Kenki-porter II) for patients with suspected empyema
Region
| Japan |
Condition
Condition
Bacterial pleuritis and empyema
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the identification rate of causative pathogens among three containers, including Kenki-porter II as a transport container for anaerobic bacteria, a sterilization container, and a blood culture bottle
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification rate of causative pathogens
Key secondary outcomes
Causative microorganisms
Thirty-day mortality
In-hospital mortality
Rate of surgery
Length of hospital stay
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients suspected to have bacterial pleuritis or empyema
2. Pleural effusion present
3. Patients who have provided informed consent, either themselves or their proxy
Key exclusion criteria
Hospital-acquired pneumonia patients
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Ito |
Organization
Ohara Healthcare Foundation, Kurashiki Central Hospital
Division name
Department of Respiratory Medicine
Zip code
710-8602
Address
Miwa 1-1-1, Kurashiki, Okayama
TEL
086-422-0210
ai12306@kchnet.or.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Ito |
Organization
Ohara Healthcare Foundation, Kurashiki Central Hospital
Division name
Department of Respiratory Medicine
Zip code
710-8602
Address
Miwa 1-1-1, Kurashiki, Okayama
TEL
086-422-0210
Homepage URL
ai12306@kchnet.or.jp
Sponsor or person
Institute
Ohara Healthcare Foundation, Kurashiki Central Hospital, Department of Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Ohara Healthcare Foundation, Kurashiki Central Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurashiki Central Hospital Ethics Committee
Address
Miwa 1-1-1, Kurashiki, Okayama
Tel
086-422-0210
kenkyu@kchnet.or.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
公益財団法人大原記念倉敷中央医療機構 倉敷中央病院(岡山県)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 20 | 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
| 2020 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
This study is a prospective observational study.
All patients suspected bacterial pleuritis or empyema are enrolled.
Pleural effusion is injected into three containers including Kenki-porter II as a transport container for anaerobic bacteria, a sterilization container, and a blood culture bottle, respectively.
Identification rate of causative pathogens and causative microorganisms are investigated.
Management information
Registered date
| 2020 | Year | 07 | Month | 16 | Day |
Last modified on
| 2023 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046970
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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