UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006985 |
|---|---|
| Receipt number | R000008239 |
| Scientific Title | Nation-wide bacteriological surveillance for Streptococcus pneumoniae in Pediatric invasive pneumococcal disease |
| Date of disclosure of the study information | 2012/01/04 |
| Last modified on | 2023/01/05 11:39:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Nation-wide bacteriological surveillance for Streptococcus pneumoniae in Pediatric invasive pneumococcal disease
Acronym
Nation-wide bacteriological surveillance for Streptococcus pneumoniae in Pediatric invasive pneumococcal disease
Scientific Title
Nation-wide bacteriological surveillance for Streptococcus pneumoniae in Pediatric invasive pneumococcal disease
Scientific Title:Acronym
Nation-wide bacteriological surveillance for Streptococcus pneumoniae in Pediatric invasive pneumococcal disease
Region
| Japan |
Condition
Condition
Invasive pneumococcal disease, Pneumonia, Acute otitis media
Classification by specialty
| Pneumology | Infectious disease | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our objective for the current study is to determine the serotype distribution of clinical isolates from patients developing pneumococcal diseases.
Basic objectives2
Others
Basic objectives -Others
bacterial epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Capsular serotype of clinically isolated S.pneumoniae
2) Minimum inhibitory concentration (MIC) of these isolates
3) MLST(Multilocus sequence typing)
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
| 2 | months-old | <= |
Age-upper limit
| 192 | months-old | > |
Gender
Male and Female
Key inclusion criteria
S.pneumoniae strains isolated from the following disease.
1)Invasive Pneumococcal Disease(IPD)
Requirement;
1:Diagnosed as Bacterial meningitis, Bacteremia, Pneumonia, Arthritis, Peritonitis
2:S. pneumoniae is isolated from physiologically sterile site [spinal fluid, blood, tissue fluid].
3:Age: over 2 months and under 16 years old
2)Pneumonia
Requirement;
1:Diagnosed as Pneumonia by chest X-ray, the following symptoms are observed: pyrexia, cough, dyspnea, chest pain, general malaise and/or sputum
2:Age: over 2 months and under 5 years old.
3:S.pneumoniae is isolated from sputum according to the reference article method.
3)Acute otitis media [AOM]
Requirement;
1:Diagnosed as AOM by the clinical symptoms and tympanic membrane findings.
2:Age: over 2 months and under 5 years old.
3:S.pneumoniae is isolated from specimen which is collected by Myringotomy or paracentesis of the tympanic membrane.
4:For avoiding contamination by Myringotomy, the specimen is collected by seed-swab.
Key exclusion criteria
None
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Fujisawa |
Organization
National Hospital Organization Mie National Hospital
Division name
-
Zip code
514-0125
Address
357 Osato-kubota, Tsu-city, Mie Japan
TEL
059-232-2531
info@pneumocatch.jp
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Izutsu |
Organization
CTD inc.
Division name
Pneumocatch research office
Zip code
104-0042
Address
4th Floor,1-2-9 Irifune, Tyuo-ku, Tokyo, Japan
TEL
81-3-6228-4835
Homepage URL
http://pneumocatch.jp/index.html
info@pneumocatch.jp
Sponsor or person
Institute
Takao Fujisawa
Institute
Department
Personal name
Funding Source
Organization
Pfizer Japan inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Mie Hospital Ethics Review Committee
Address
357 Osato-kubota, Tsu-city, Mie, Japan
Tel
81-59-232-2531
iguchi@mie-m.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
三重病院、その他全国の医療機関
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
http://www.pneumocatch.jp/
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
| 2011 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
S. pneumoniae is one of the most common and serious pathogen of pediatric bacterial infectious diseases including meningitis, bacteremia, pneumonia and acute otitis media. In February 2010, Prevenar®, 7-valent pneumococcal conjugate vaccine: hereinafter referred to as PCV7, has been launched in Japan as an only available pneumococcal conjugate vaccine in the country. Significant drop of IPD incidence has been demonstrated in the US where PCV7 has been used for 10 years, and similar trend is reasonably expected in Japan as well. However, emergence of IPD caused by non-PCV serotype, particularly serotype 19A, has been noted in the US and other countries, and this could be reproduced also in Japan. In Japan, survey for pneumococcal capsular serotype of IPD has been conducted in limited area, and it is anticipated that PCV7 could cover about 70% according to the analysis for the rate of pneumococcal capsular serotype, which tends to increase pneumococcal of antibiotic- resistant strain every year. This means that it must be an extremely important key survey to monitor how pneumococcal capsular serotype of IPD will be changed after introducing PCV7.
In the current study, we sought to determine bacteriological aspect of pneumococcal infection in Japanese children.
Management information
Registered date
| 2011 | Year | 12 | Month | 28 | Day |
Last modified on
| 2023 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008239
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
