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 |
Evaluation of a novel genetic testing system for detection of macrolide resistance Mycoplasma pneumoniae
Evaluation of a novel genetic testing system for detection of macrolide resistance Mycoplasma pneumoniae
Evaluation of a novel genetic testing system for detection of macrolide resistance Mycoplasma pneumoniae
Evaluation of a novel genetic testing system for detection of macrolide resistance Mycoplasma pneumoniae
Japan |
Mycoplasma pneumoniae infection
Pneumology | Infectious disease |
Others
NO
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.
Efficacy
Detection performance of Mycoplasma pneumoniae gene
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Device,equipment |
(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.).
1 | years-old | <= |
Not applicable |
Male and Female
(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.
(1) Patients who could not collect enough samples for evaluation.
(2) Patients who the research director judged inappropriate as a research subject.
150
1st name | Toshihiko |
Middle name | |
Last name | Kakiuchi |
Faculty of Medicine, Saga University
Department of Pediatrics
8498501
5-1-1 Nabeshima, Saga-shi, Saga, Japan
0952-34-2314
kakiucht@cc.saga-u.ac.jp
1st name | Toshihiko |
Middle name | |
Last name | Kakiuchi |
Faculty of Medicine, Saga University
Department of Pediatrics
8498501
5-1-1 Nabeshima, Saga-shi, Saga, Japan
0952-34-2314
kakiucht@cc.saga-u.ac.jp
Saga University
Saga University
Japanese Governmental office
Department of Pediatrics, Kawasaki Medical School
MIZUHO MEDY Co Ltd.
Clinical Research Center, Saga University Hospital
5-1-1 Nabeshima, Saga-shi, Saga, Japan
0952-34-3400
kenkyu-shinsei@ml.cc.saga-u.ac.jp
NO
東京都
2019 | Year | 05 | Month | 20 | Day |
https://jcm.asm.org/content/early/2021/04/23/JCM.03245-20
Published
https://jcm.asm.org/content/early/2021/04/23/JCM.03245-20
150
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.
2021 | Year | 05 | Month | 22 | Day |
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%).
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%).
None
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
Completed
2018 | Year | 11 | Month | 05 | Day |
2018 | Year | 11 | Month | 05 | Day |
2018 | Year | 11 | Month | 05 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 05 | Month | 31 | Day |
2020 | Year | 11 | Month | 25 | Day |
2020 | Year | 11 | Month | 25 | Day |
2019 | Year | 05 | Month | 20 | Day |
2023 | Year | 08 | Month | 23 | Day |
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 |