UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049902 |
|---|---|
| Receipt number | R000056836 |
| Scientific Title | Prospective and retrospective observational study on the outcome of treatment with various antimicrobial agents in Mycoplasma genitalium urethritis |
| Date of disclosure of the study information | 2022/12/26 |
| Last modified on | 2022/12/26 14:21:01 |
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Basic information
Public title
Prospective and retrospective observational study on the outcome of treatment with various antimicrobial agents in Mycoplasma genitalium urethritis
Acronym
Study on the Outcome of Mycoplasma genitalium urethritis treatment
Scientific Title
Prospective and retrospective observational study on the outcome of treatment with various antimicrobial agents in Mycoplasma genitalium urethritis
Scientific Title:Acronym
Study on the Outcome of Mycoplasma genitalium urethritis treatment
Region
| Japan |
Condition
Condition
Mycoplasma genitalium urethritis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the clinical efficacy of various antimicrobial agents against Mycoplasma genitalium infections.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate efficacy rates (effect on subjective symptoms, effect on pyuria, and bacteriological effect) and adverse events with various antimicrobial treatments.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Patients diagnosed with nongonococcal urethritis
Patients who give consent to participate in this study
Key exclusion criteria
Patients who have refused to participate in this study by submitting a publicly available opt-out document
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Yasuda |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Infection Control & Laboratory Medicine
Zip code
060-8543
Address
S1 W16, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
yasuda7jpe@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Yasuda |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Infection Control & Laboratory Medicine
Zip code
060-8543
Address
S1 W16, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
Homepage URL
yasuda7jpe@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University School of Medicine
Address
S1 W17, Chuo-ku, Sapporo, Hokkaido
Tel
011-611-2111
ji-rskk@sapmed.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 26 | 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
| 2022 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Compare treatment outcomes with a single oral dose of azithromycin 1g, the standard of care.
Management information
Registered date
| 2022 | Year | 12 | Month | 26 | Day |
Last modified on
| 2022 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056836
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
