UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013792 |
|---|---|
| Receipt number | 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 16:56:12 |
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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
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
ac090239@akita-city-hp.jp
Sponsor or person
Institute
Akita City Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
