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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006985
Receipt No. 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 2020/03/02

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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
Email 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 104-0045
Address 2-7-3Tsukiji, Tyuo-ku, Tokyo, Japan
TEL 81-3-6228-4881
Homepage URL http://pneumocatch.jp/index.html
Email info@pneumocatch.jp

Sponsor
Institute Takao Fujisawa
Institute
Department

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
Email 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 01 Month 31 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&reg;, 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
2020 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.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


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