UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038327 |
|---|---|
| Receipt number | R000043682 |
| Scientific Title | Evaluation of rapid diagnostic test for mycoplasma infection |
| Date of disclosure of the study information | 2021/12/31 |
| Last modified on | 2025/04/22 09:15:29 |
* 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 assay kit for detecting mycoplasma infection
Acronym
Evaluation of assay kit for detecting mycoplasma infection
Scientific Title
Evaluation of rapid diagnostic test for mycoplasma infection
Scientific Title:Acronym
Evaluation of rapid diagnostic test for mycoplasma infection
Region
| Japan |
Condition
Condition
Mycoplasma infection
Classification by specialty
| Infectious disease | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of rapid diagnostic test for mycoplasma infection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity, specificity and detection limit of rapid diagnostic test for mycoplasma infection
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Sample collection, assay with test kit
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 that visit the medical institution during this study, and include the following conditions:
1) Patients with suspected mycoplasma infection based on symptoms.
2) Patients who agree to participate in this study.
Key exclusion criteria
1) Patients who are difficult to obtain clinical samples from.
2) For any reason other than above, patients who were determined by doctor as being unfit to participate in this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Mitamura |
Organization
Eiju General Hospital
Division name
Division for infection control
Zip code
1108645
Address
2-23-16 Higashi-ueno, Taito-ku Tokyo 110-8645, Japan
TEL
03-3833-8381
mitamurakeiko77@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Maehara |
Organization
Sekisui Medical Co., Ltd.
Division name
Research & Development
Zip code
1030027
Address
1-3 Nihonbashi 2-chome, Chuo-ku Tokyo 103-0027, Japan
TEL
03-3272-0677
Homepage URL
yuta.maehara@sekisui.com
Sponsor or person
Institute
Sekisui Medical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Sekisui Medical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Zama Children's Clinic, Abe Children's Clinic, Kobayashi International Clinic, Koukan Clinic, Jichi Medical University Hospital, Shin-Oyama City Hospital, Aichi Medical University Hospital, Chuno Kosei Hospital, Matsubara Otolaryngology Clinic, Hara Children's Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Eiju General Hospital Ethics Review Committee
Address
2-23-16 Higashi-ueno, Taito-ku Tokyo 110-8645, Japan
Tel
03-3833-8381
eiju@eijuhp.com
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
永寿総合病院（東京都）、座間小児科診療所（神奈川県）、あべこどもクリニック（神奈川県）、小林国際クリニック（神奈川県）、こうかんクリニック（神奈川県）、自治医科大学（栃木県）、新小山市民病院（栃木県）、愛知医科大学（愛知県）、中濃厚生病院（岐阜県）、松原耳鼻いんこう科医院（岐阜県）、原小児科（広島県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Since the epidemic of infectious diseases in Japan is unstable due to the influence of COVID-19, the trial period has been extended.
Management information
Registered date
| 2019 | Year | 10 | Month | 18 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043682
