UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035892 |
|---|---|
| Receipt number | R000040299 |
| Scientific Title | A prospective study for an evaluation of a novel rapid kit detecting pathogenic bacteria among patients with acute otitis media and rhinosinusitis |
| Date of disclosure of the study information | 2019/02/16 |
| Last modified on | 2019/10/02 20:25:37 |
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Basic information
Public title
A prospective study for an evaluation of a novel rapid kit detecting pathogenic bacteria among patients with acute otitis media and rhinosinusitis
Acronym
An evaluation of a novel rapid detection kit for pathogenic bacteria of acute otitis media and rhinosinusitis
Scientific Title
A prospective study for an evaluation of a novel rapid kit detecting pathogenic bacteria among patients with acute otitis media and rhinosinusitis
Scientific Title:Acronym
An evaluation of a novel rapid detection kit for pathogenic bacteria of acute otitis media and rhinosinusitis
Region
| Japan |
Condition
Condition
acute otitis media and acute rhinosinusitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating a novel rapid detection kit for Streptococcus pneumoniae and Haemophilus influenzae, causative bacterial pathogens of acute otitis media and rhinosinusitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison between a novel detection kit and bacterial culture and PCR from same samples
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with acute otitis media or acute rhinosinusitis who or whose guardian accept to participate in this study
Key exclusion criteria
Difficulty of sampling
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Muneki Hotomi |
Organization
Wakayama Medical University
Division name
Otorhinolaryngology-Head and Neck Surgery
Zip code
Address
811-1, Kimiidera, Wakayama
TEL
0734472300
mhotomi@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masamitsu Kono |
Organization
Wakayama Medical University
Division name
Otorhinolaryngology-Head and Neck Surgery
Zip code
Address
811-1, Kimiidera, Wakayama
TEL
0734472300
Homepage URL
ma332jp@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei Corporation
Organization
Division
Category of Funding Organization
Profit organization
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
| 2019 | Year | 02 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter prospective study
Target Disease: Acute otitis media or acuterhinosinusitis
Study period: December, 2018-June, 2020
Management information
Registered date
| 2019 | Year | 02 | Month | 16 | Day |
Last modified on
| 2019 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040299
