UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036804
Receipt No. R000041935
Scientific Title Evaluation of a novel genetic testing system for detection of macrolide resistance Mycoplasma pneumoniae
Date of disclosure of the study information 2019/05/20
Last modified on 2019/05/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of a novel genetic testing system for detection of macrolide resistance Mycoplasma pneumoniae
Acronym Evaluation of a novel genetic testing system for detection of macrolide resistance Mycoplasma pneumoniae
Scientific Title Evaluation of a novel genetic testing system for detection of macrolide resistance Mycoplasma pneumoniae
Scientific Title:Acronym Evaluation of a novel genetic testing system for detection of macrolide resistance Mycoplasma pneumoniae
Region
Japan

Condition
Condition Mycoplasma pneumoniae infection
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the performance of newly developed instruments and reagents in terms of both the ability to detect Mycoplasma pneumoniae genes and gene mutations in macrolide-resistant Mycoplasma pneumoniae.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection performance of Mycoplasma pneumoniae gene
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 (1). Perform a test with the Mycoplasma pneumoniae antigen rapid test kit.
(2).Conduct the test using this research test reagent and equipment. Nucleic acid extraction is performed using the residual sample solution (Mizuhomedy Co., Ltd.). Using the extracted nucleic acid, presence or absence of pneumonia mycoplasma gene by real-time PCR method, presence or absence of gene mutation of macrolide resistant pneumonia mycoplasma using A gene mutation analysis method (A 2063 C, A 2063 G, A 2064 G of 23S rRNA domain V) To measure (Kawasaki Medical School of Pediatrics).
(3). Perform isolation and drug sensitivity test of Mycoplasma pneumoniae (Mizuhomedy Co., Ltd.).
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
1 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients aged 1 and over at the time of consent acquisition.
(2) Patients suspected of Mycoplasma pnuemoniae infection due to fever, cough, imaging test, etc.
(3) Patients considered necessary to carry out Mycoplasmdiagnostic testing/
(4) After receiving sufficient explanation for participation in this research, with sufficient understanding, patients who have obtained consent from the researcher.
Key exclusion criteria (1) Patients who could not collect enough samples for evaluation.
(2) Patients who the research director judged inappropriate as a research subject.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Toshihiko
Middle name
Last name Kakiuchi
Organization Faculty of Medicine, Saga University
Division name Department of Pediatrics
Zip code 8498501
Address 5-1-1 Nabeshima, Saga-shi, Saga, Japan
TEL 0952-34-2314
Email kakiucht@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name Toshihiko
Middle name
Last name Kakiuchi
Organization Faculty of Medicine, Saga University
Division name Department of Pediatrics
Zip code 8498501
Address 5-1-1 Nabeshima, Saga-shi, Saga, Japan
TEL 0952-34-2314
Homepage URL
Email kakiucht@cc.saga-u.ac.jp

Sponsor
Institute Saga University
Institute
Department

Funding Source
Organization Saga University
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Pediatrics, Kawasaki Medical School
Name of secondary funder(s) MIZUHO MEDY Co Ltd.

IRB Contact (For public release)
Organization Clinical Research Center, Saga University Hospital
Address 5-1-1 Nabeshima, Saga-shi, Saga, Japan
Tel 0952-34-3400
Email kenkyu-shinsei@ml.cc.saga-u.ac.jp

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 東京都

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 20 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 11 Month 05 Day
Date of IRB
2018 Year 11 Month 05 Day
Anticipated trial start date
2018 Year 11 Month 05 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

Management information
Registered date
2019 Year 05 Month 20 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041935

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.