UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009194 |
|---|---|
| Receipt number | R000005864 |
| Scientific Title | Phase variation of S. pneumoniae isolated from children with acute otitis media. |
| Date of disclosure of the study information | 2012/10/26 |
| Last modified on | 2017/07/28 10:41:10 |
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Basic information
Public title
Phase variation of S. pneumoniae isolated from children with acute otitis media.
Acronym
Phase variation of S. pneumoniae isolated from children with acute otitis media.
Scientific Title
Phase variation of S. pneumoniae isolated from children with acute otitis media.
Scientific Title:Acronym
Phase variation of S. pneumoniae isolated from children with acute otitis media.
Region
| Japan |
Condition
Condition
Acute otitis media
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study was designed to investigate the morphological phase variation, serotypes, antimicrobial susceptibilities, genotypes of penicillin binding proteins and DNA polymorphysm of pneumococci isolated from children with acute otitis media.
Basic objectives2
Others
Basic objectives -Others
The decimal fraction of total colonies that were opaque was determined for each isolate from nasopharynx and middle ear fluids.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The decimal fraction of total colonies that were opaque was determined for each isolate from nasopharynx and middle ear fluids.
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
| Not applicable |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Children below 15 years of ages with moderate and severe acute otitis media who had not previously been treated with antibiotics.
Key exclusion criteria
none
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Muneki Hotomi |
Organization
Wakayama Medical University
Division name
Otolaryngology-Head and Neck Surgery
Zip code
Address
811-1 Kimiidera, Wakayama-shi, Wakayama 641-8509, Japan
TEL
073-447-2300
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Muneki Hotomi |
Organization
Wakayama Medical University
Division name
Otolaryngology-Head and Neck Surgery
Zip code
Address
811-1 Kimiidera, Wakayama-shi, Wakayama 641-8509, Japan
TEL
073-447-2300
Homepage URL
Sponsor or person
Institute
Wakayama-Okayama Otolaryngology Pharma
Institute
Department
Personal name
Funding Source
Organization
Wakayama-Okayama Otolaryngology Pharma
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2012 | Year | 10 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | 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
The decimal fraction of total colonies that were opaque was determined for each isolate from nasopharynx and middle ear fluids.
Management information
Registered date
| 2012 | Year | 10 | Month | 26 | Day |
Last modified on
| 2017 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005864
