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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035892
Receipt No. 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

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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
Email 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
Email ma332jp@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040299

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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