UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012726 |
|---|---|
| Receipt number | R000014865 |
| Scientific Title | A study about pathogenic diagnosis of pediatric atypical pneumonia |
| Date of disclosure of the study information | 2013/12/29 |
| Last modified on | 2013/12/29 14:52:48 |
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Basic information
Public title
A study about pathogenic diagnosis of pediatric atypical pneumonia
Acronym
A study about pathogenic diagnosis of pediatric atypical pneumonia
Scientific Title
A study about pathogenic diagnosis of pediatric atypical pneumonia
Scientific Title:Acronym
A study about pathogenic diagnosis of pediatric atypical pneumonia
Region
| Japan |
Condition
Condition
Mycoplasma pneumoniae pneumonia
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Mycoplasma pneumoniae is a common cause of community-acquired pneumonia in children and young adults. DNA detection using the loop-mediated isothermal amplification (LAMP) assay has been recommended for a definitive diagnosis in the acute phase of M. pneumoniae infection, but studies evaluating the clinical utilities of this assay are limited.
In this study, the diagnostic efficacy of the loop-mediated isothermal amplification (LAMP) assay for M. pneumoniae pneumonia in clinical practice was prospectively evaluated. Additionally, the incidence of drug resistance to macrolides was examined in M. pneumoniae detected.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) The detection rate of M. pneumoniae DNA by LAMP assay
2) Comparison of clinical utilities with serological method
3) Search for clinical and genetical resistance to macrolides
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
| 0 | years-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Children diagnosed with community-acquired pneumonia with an agreement of a parent on this study, who were admitted to Konan Kosei Hospital between September 2009 and March 2012.
Key exclusion criteria
We excluded the subjects from whom throat swabs were not obtained.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoko Nishimura |
Organization
Konan Kosei Hospital
Division name
Department of Pediatrics
Zip code
Address
137 Ohmatsubara, Takaya-cho, Konan, Aichi
TEL
0587-51-3333
naon@konan.jaaikosei.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko Nishimura |
Organization
Konan Kosei Hospital
Division name
Department of Pediatrics
Zip code
Address
137 Ohmatsubara, Takaya-cho, Konan, Aichi
TEL
0587-51-3333
Homepage URL
naon@konan.jaaikosei.or.jp
Sponsor or person
Institute
Konan Kosei Hospital
Institute
Department
Personal name
Funding Source
Organization
Konan Kosei Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 12 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We presented the results at the 45th annual meeting of the Japanese Society for Pediatric Infectious Diseases on October 27, 2013.
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
Completed
Date of protocol fixation
| 2009 | Year | 08 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | 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
Prospective study
Management information
Registered date
| 2013 | Year | 12 | Month | 29 | Day |
Last modified on
| 2013 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014865
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