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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011280
Receipt No. R000013218
Scientific Title Research on relationship between the causative bacterium of pulmonary abscess or pyothorax with oral bacteria
Date of disclosure of the study information 2013/07/26
Last modified on 2018/01/28

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Basic information
Public title Research on relationship between the causative bacterium of pulmonary abscess or pyothorax with oral bacteria
Acronym Research on DNA homology of the causative bacterium of pulmonary abscess or pyothorax with oral bacteria
Scientific Title Research on relationship between the causative bacterium of pulmonary abscess or pyothorax with oral bacteria
Scientific Title:Acronym Research on DNA homology of the causative bacterium of pulmonary abscess or pyothorax with oral bacteria
Region
Japan

Condition
Condition Pulmonary abscess, pyothorax
Classification by specialty
Pneumology Infectious disease Oral surgery
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether the causative bacterium of pulmonary abscess or pyothorax derives from oral cavity
Basic objectives2 Others
Basic objectives -Others DNA homology of the causative bacterium of pulmonary abscess or pyothorax with oral bacteria
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes analysis of DNA sequence of the causative bacterium of pulmonary abscess or pyothorax and DNA homology with oral bacteria
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with pulmonary abscess or pyothorax who are hospitalized in
Himeji Medical Center and satisfy the following criteria;
1) Patients who require percutaneous needle aspiration for diagnosis
2) Patients who agree to participate this study
Key exclusion criteria We exclude patients who doctor consider inappropriate.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuharu Nakahara
Organization National Hospital Organization Himeji Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 68 Honmachi, Himeji-shi, Hyogo
TEL 079-225-3211
Email nakaharay@hmj-net.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rinko Katsuda
Organization National Hospital Organization Himeji Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 68 Honmachi, Himeji-shi, Hyogo
TEL 079-225-3211
Homepage URL
Email rkatsuda@hmj-net.hosp.go.jp

Sponsor
Institute National Hospital Organization Himeji Medical Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Sunstar Inc.
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 国立病院機構 姫路医療センター(兵庫県)

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 26 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Genetic homology between bacteria from pyothorax and from oral cavity has been proved.
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 No longer recruiting
Date of protocol fixation
2013 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 26 Day
Last follow-up date
2016 Year 07 Month 31 Day
Date of closure to data entry
2017 Year 08 Month 31 Day
Date trial data considered complete
2018 Year 01 Month 27 Day
Date analysis concluded

Other
Other related information Relationship between pulmonary abscess or pyothorax is suspected but not proved yet.

Management information
Registered date
2013 Year 07 Month 26 Day
Last modified on
2018 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013218


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