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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013792
Receipt No. R000016100
Scientific Title A molecular epidemiological study of respiratory viruses and bacterial infection/colonization in Japanese children with acute wheezing illness
Date of disclosure of the study information 2014/04/23
Last modified on 2014/04/23

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Basic information
Public title A molecular epidemiological study of respiratory viruses and bacterial infection/colonization in Japanese children with acute wheezing illness
Acronym An study of respiratory viruses and bacterial colonization in Japanese asthmatic children
Scientific Title A molecular epidemiological study of respiratory viruses and bacterial infection/colonization in Japanese children with acute wheezing illness
Scientific Title:Acronym An study of respiratory viruses and bacterial colonization in Japanese asthmatic children
Region
Japan

Condition
Condition Children with wheezing confirmed by pediatricians at least once.
infantile asthma, asthma
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Recent studies suggest that some particular viral infection and/or bacterial infection/colonization exacerbates wheezy condition across all age groups in children.
In this study we examine the association between viral infection and/or bactrerial colonization in nasopharyngeal secretions in patients who experience at least one wheezing episode confirmed by pediatrician, then,
evaluate the suitable way for management of wheezing condition(i.e. the efficacy of leukotriene receptor antagonist, inhaled corticosteroids, and antibiotics)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the results of viral isolation and bacterial culture in nasopharyngeal secretions
Severity of wheezing episodes (need for hospitalization)
Key secondary outcomes The points of Childhood asthma control test,
The points of Japanese Pediatric Asthma Control Program,
length of hospital stay,
length of oxygen requirement,
lowest oxygen saturation,
incidence of systemic administration of corticosteroids,
the result of blood test

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
0 years-old <=
Age-upper limit
15 years-old >
Gender Male and Female
Key inclusion criteria Children that visit pediatric outpatient clinic or are admitted pediatric ward.
Children whose parents give informed consent.
Key exclusion criteria Children that visit emergency room.
Children whose parents do not give informed consent.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wako Ishida
Organization Akita City Hospital
Division name Pediatrics
Zip code
Address 4-30, Kawamoto Matsuokacho, Akita, Akita
TEL 018-823-4171
Email ac090239@akita-city-hp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Wako Ishida
Organization Akita City Hospital
Division name Pediatrics
Zip code
Address 4-30, Kawamoto Matsuokacho, Akita, Akita
TEL 018-823-4171
Homepage URL
Email ac090239@akita-city-hp.jp

Sponsor
Institute Akita City Hospital
Institute
Department

Funding Source
Organization Akita City Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 23 Day

Related information
URL releasing protocol
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 Enrolling by invitation
Date of protocol fixation
2014 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Respiratory syncytial virus is detected in patients with no history of wheezing.
Other viruses such as human rhinoviruses,human metapneumoviruses, human bocaviruses, and human parainfluenza viruses are dominant in patients with such history.
The patients who require hospitalization are colonized with Moraxella catarrhalis as well as Haemophilus influenza and Streptococcus pneumonia.
The patients with bacterial colonization in nasal cavity tend to experience exacerbation of wheezy episode.
Bacterial colonization in nasopharynx contributes to exacerbation of wheezing episode.
Haemophilus influenza and Streptococcus pneumonia are frequently detected during wheezing episode.
The coexistence of viral infection and the bacterial infection/colonization increases the severity of wheezy condition.
Leukotriene receptor antagonists inhibit repetition of wheezing episodes.
Inhaled corticosteroids inhibit exacerbation of wheezing episodes in children over the age of 5 years old.



Management information
Registered date
2014 Year 04 Month 23 Day
Last modified on
2014 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016100

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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