UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011280 |
|---|---|
| Receipt number | 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 | 2023/02/06 17:34:16 |
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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
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
| 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 | Yasuharu |
| Middle name | |
| Last name | Nakahara |
Organization
National Hospital Organization Himeji Medical Center
Division name
Department of Respiratory Medicine
Zip code
670-8520
Address
68 Honmachi, Himeji-shi, Hyogo
TEL
079-225-3211
nakahara.yasuharu.zv@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Rinko |
| Middle name | |
| Last name | Katsuda |
Organization
National Hospital Organization Himeji Medical Center
Division name
Department of Respiratory Medicine
Zip code
670-0974
Address
68 Honmachi, Himeji-shi, Hyogo
TEL
079-225-3211
Homepage URL
katsuda.rinko.ck@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Himeji Medical Center
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
Sunstar Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Himeji Medical Center IRB
Address
68 Honmachi, Himeji-shi, Hyogo
Tel
079-225-3211
katsuda.rinko.ck.@mail.hosp.go.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
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
doi: 10.1128/spectrum.00974-21
Publication of results
Published
Result
URL related to results and publications
doi: 10.1128/spectrum.00974-21
Number of participants that the trial has enrolled
29
Results
Genetic homology between bacteria from pyothorax and from oral cavity has been proved.
Results date posted
| 2023 | Year | 02 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The enrolled participants included 29 patients with pulmonary abscess (n = 19) or pyothorax (n = 10) who visited the Himeji Medical Center respiratory medicine department between August 2013 and March 2015.
Participant flow
Patients were assigned to the pulmonary abscess group when they presented pulmonary infections with a mass-like consolidation in the thoracic cavity or low-density areas within the lesions upon examination using contrast-enhanced chest CT. Those patients then underwent sampling of their lesions for isolation of bacteria. Patients were diagnosed with pyothorax when they showed fever and pleural effusions which included bacterial contaminants.
Adverse events
Nothing.
Outcome measures
To prove that genetically identical bacterial strains exist both in oral microbiota and in pus specimen which were obtained percutaneously without oral contamination from pulmonary abscesses and pyothorax.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 21 | Day |
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
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013218
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