UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036804
Receipt number 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 2023/08/23 09:13:46

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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 or person

Institute

Saga University

Institute

Department

Personal name



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

https://jcm.asm.org/content/early/2021/04/23/JCM.03245-20

Publication of results

Published


Result

URL related to results and publications

https://jcm.asm.org/content/early/2021/04/23/JCM.03245-20

Number of participants that the trial has enrolled

150

Results

A clinical evaluation of SmartGene TM Myco was conducted in 150 children suspected of being infected with M. pneumoniae. The sensitivity when using real-time PCR as a control was 97.8%, the specificity was 93.3%, and the concordance rate for macrolide resistance mutation determination when using sequence analysis as a control was 100%. Post-test antibiotic change rates were significantly higher in patients with mutations.

Results date posted

2021 Year 05 Month 22 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Informed consent was obtained among those suspected of having M. pneumoniae infection in four pediatric departments (three primary care institutions and one tertiary care institution) from January to December 2019. 150 cases were registered. The gender breakdown of the 150 cases evaluated was 81 males (54.0%) and 69 females (46.0%).

Participant flow

Informed consent was obtained among those suspected of having M. pneumoniae infection in four pediatric departments (three primary care institutions and one tertiary care institution) from January to December 2019. 150 cases were registered. The gender breakdown of the 150 cases evaluated was 81 males (54.0%) and 69 females (46.0%).

Adverse events

None

Outcome measures

Correlation evaluation between Smart Gene TM and real-time PCR
Correlation evaluation of Smart Gene TM and sequence analysis for MR mutations
MR mutations rate by facility
Presence or absence of MLs premedication and MR mutations rate

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

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

2020 Year 05 Month 31 Day

Date trial data considered complete

2020 Year 11 Month 25 Day

Date analysis concluded

2020 Year 11 Month 25 Day


Other

Other related information



Management information

Registered date

2019 Year 05 Month 20 Day

Last modified on

2023 Year 08 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041935


Research Plan
Registered date File name
2021/05/22 (FIX)実施計画書_180926_protocol_sample_ver1.1.docx

Research case data specifications
Registered date File name
2021/05/22 20200716ML耐性Myco遺伝子臨床試験_表・グラフ追加分(㈱ミズホメディー).pdf

Research case data
Registered date File name
2021/05/22 20200716ML耐性Myco遺伝子臨床試験_表・グラフ追加分(㈱ミズホメディー).pdf