UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063443 |
|---|---|
| Receipt number | R000072615 |
| Scientific Title | Antimicrobial Susceptibility Surveillance - Obstetric and Gynecological Infections- |
| Date of disclosure of the study information | 2026/10/28 |
| Last modified on | 2026/10/28 13:41:12 |
* 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
Nationwide Antimicrobial Susceptibility Surveillance by Four Japanese Academic Societies- Obstetric and Gynecological Infections-
Acronym
Nationwide Antimicrobial Susceptibility Surveillance by Four Japanese Academic Societies- Obstetric and Gynecological Infections-
Scientific Title
Antimicrobial Susceptibility Surveillance - Obstetric and Gynecological Infections-
Scientific Title:Acronym
Antimicrobial Susceptibility Surveillance - Obstetric and Gynecological Infections-
Region
| Japan |
Condition
Condition
Obstetric and gynecological infections
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the susceptibility of causative bacteria isolated from patients with obstetric and gynecological infections to various antimicrobial agents and to characterize the current status of antimicrobial resistance.
Basic objectives2
Others
Basic objectives -Others
To determine the susceptibility of causative bacteria isolated from patients with obstetric and gynecological infections to various antimicrobial agents and to characterize the current status of antimicrobial resistance.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Antimicrobial susceptibility of causative bacteria isolated from patients with obstetric and gynecological infections
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients with obstetric and gynecological infections caused by Streptococcus agalactiae or Prevotella bivia.
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroshige |
| Middle name | |
| Last name | Mikamo |
Organization
Aichi Medical University
Division name
School of Medicine
Zip code
4801195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561623311
mikamo@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshige |
| Middle name | |
| Last name | Mikamo |
Organization
Aichi Medical University
Division name
School of Medicine
Zip code
4801195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561623311
Homepage URL
mikamo@aichi-med-u.ac.jp
Sponsor or person
Institute
The Committee of Four Academic Societies Joint Antimicrobial Susceptibility Surveillance Program
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Chemotherapy, the Japanese Association for Infectious Diseases, and the Japanese Society for Clinical Microbiology and Japanese Society for Infection Prevention and Control
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
Aichi Medical University
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
Tel
0561-62-3311
aichi-med@esct.bvits.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 28 | 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
| 2025 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nationwide Surveillance
Management information
Registered date
| 2026 | Year | 10 | Month | 28 | Day |
Last modified on
| 2026 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072615
