UMIN-CTR Clinical Trial

Basic information
Public title	Antimicrobial susceptibility surveillance: acute uncomplicated cystitis 2020
Acronym	Antimicrobial susceptibility surveillance: acute uncomplicated cystitis 2020
Scientific Title	Antimicrobial susceptibility surveillance: acute uncomplicated cystitis 2020
Scientific Title:Acronym	Antimicrobial susceptibility surveillance: acute uncomplicated cystitis 2020
Region	Japan

Condition
Condition	acute uncomplicated cystitis
Classification by specialty	Infectious disease Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To review the antimicrobial susceptibility isolated from the patients with acute uncomplicated cystitis
Basic objectives2	Others
Basic objectives -Others	National surveillance
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	antimicrobial susceptibility of isolated pathogen
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	16 years-old <=
Age-upper limit	100 years-old >=
Gender	Female
Key inclusion criteria	Age Female Outpatient Urinary symptoms Pyuria
Key exclusion criteria	Unsuitable cases
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Takahashi
Organization	Sapporo Medical University School of Medicine
Division name	Department of Infection Control and Laboratory Medicine
Zip code	0608543
Address	S1, W16, Chuoku, Sapporo, Japan
TEL	0116112111
Email	stakahas@sapmed.ac.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Takahashi
Organization	Sapporo Medical University School of Medicine
Division name	Department of Infection Control and Laboratory Medicine
Zip code	0608543
Address	S1, W16, Chuoku, Sapporo, Japan
TEL	0116112111
Homepage URL
Email	stakahas@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization	Three Society of antimicrobial susceptibility surveillance
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	IRB committee in Sapporo Medical University Hospital
Address	S1, W16, Chuo-ku, Sapporo, Japan
Tel	0116112111
Email	stakahas@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	2020 Year 08 Month 21 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	2020 Year 04 Month 09 Day
Date of IRB	2020 Year 04 Month 09 Day
Anticipated trial start date	2020 Year 04 Month 10 Day
Last follow-up date	2022 Year 08 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2020 Year 08 Month 21 Day
Last modified on	2020 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047382