UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037116 |
|---|---|
| Receipt number | R000042289 |
| Scientific Title | Nationwide surveillance of bacterial respiratory pathogens conducted by the Surveillance Committee of Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Clinical Microbiology. |
| Date of disclosure of the study information | 2019/06/20 |
| Last modified on | 2023/06/22 10:17:18 |
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Basic information
Public title
Nationwide surveillance of bacterial respiratory pathogens conducted by the Surveillance Committee of Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Clinical Microbiology.
Acronym
Nationwide surveillance of bacterial respiratory pathogens by three academic societies.
Scientific Title
Nationwide surveillance of bacterial respiratory pathogens conducted by the Surveillance Committee of Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Clinical Microbiology.
Scientific Title:Acronym
Nationwide surveillance of bacterial respiratory pathogens by three academic societies.
Region
| Japan |
Condition
Condition
Respiratory infection
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the susceptibility of the causative bacteria isolated from patients with adult respiratory tract infections to various antimicrobial agents, and will examine the distribution of isolates and sensitivity by patient background and region over time.
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Susceptibility of isolated causative strains to various antibiotics
Key secondary outcomes
Isolation frequency of antimicrobial resistant bacteria
Analysis by area and facility
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
Patients of real age 20 years or older.
Patients with respiratory infections that are affected by Community acquired pneumonia(CAP), Nursing and Healthcare-associated pneumonia(NHCAP), Hospital acquired pneumonia(HAP), Ventilator Associated Pneumonia(VAP), secondary infection with chronic respiratory disease, etc., and who are expected to isolate the causative organism, or who have the causative organism isolated.
Key exclusion criteria
A patient who is deemed inappropriate by the researchers.
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | Issei |
| Middle name | |
| Last name | Tokimatsu |
Organization
Showa University School of Medicine
Division name
Department Medicine, Division of Clinical Infectious Diseases
Zip code
1428555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8777
issei@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Issei |
| Middle name | |
| Last name | Tokimatsu |
Organization
Showa University School of Medicine
Division name
Department Medicine, Division of Clinical Infectious Diseases
Zip code
1428555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8777
Homepage URL
http://www.3ssp.jp/
issei@med.showa-u.ac.jp
Sponsor or person
Institute
The Surveillance Committee of Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Clinical Microbiology.
Institute
Department
Personal name
Funding Source
Organization
The Surveillance Committee of Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Clinical Microbiology.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of Medicine, Showa University ETHUCAL COMMITTEE
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8129
m-rinri@ofc.showa-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/37116613/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37116613/
Number of participants that the trial has enrolled
932
Results
The percentages of 932 strains collected from 32 facilities in Japan.
Results date posted
| 2023 | Year | 06 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
community-acquired pneumonia (CAP), nursing and healthcare-associated pneumonia (NHCAP), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), secondary infections of chronic respiratory diseases, and lung abscesses,
Participant flow
These isolates were judged as causative pathogens of RTI by physicians based on subjective symptoms, physical findings, laboratory findings, radiological findings, and microbiological findings such as bacterial phagocytosis by neutrophils and quantitative culture results of respiratory specimens. The isolates, which were identified as subjective bacteria in each clinical microbiology laboratory, were suspended in Microbank tubes (Cryobank: Mast Diagnostica GmbH, Reinfeld, Germany), stored in the freezer, and transferred to the central laboratory, MicroSKY Lab, Inc. (Tokyo, Japan).
Adverse events
None
Outcome measures
Brief information about the patients, including the settings, age, sex, underlying disease, outpatient/hospitalized patient, presence/absence of immunodeficiency, and presence/absence of antimicrobial pre-administration within the past 90 days, was abstracted from the Questionnaire completed by the doctors.
The susceptibilities of the bacterial strains were tested for the 42 antimicrobial agents.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
surveillance
Management information
Registered date
| 2019 | Year | 06 | Month | 19 | Day |
Last modified on
| 2023 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042289
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