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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000038633 |
Receipt No. | R000043394 |
Scientific Title | An Observational Study on the Effect of Antimicrobial Stewardship Program in ICU |
Date of disclosure of the study information | 2019/11/30 |
Last modified on | 2019/10/23 |
Basic information | ||
Public title | An Observational Study on the Effect of Antimicrobial Stewardship Program in ICU | |
Acronym | An Observational Study on the Effect of Antimicrobial Stewardship Program in ICU | |
Scientific Title | An Observational Study on the Effect of Antimicrobial Stewardship Program in ICU | |
Scientific Title:Acronym | An Observational Study on the Effect of Antimicrobial Stewardship Program in ICU | |
Region |
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Condition | |||
Condition | Infectious disease | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | We will analyze 1) the use of antimicrobial drugs, 2) the pattern of antimicrobial resistant bacteria and 3) the prognosis of patients who received antimicrobial drugs prior to and after the inception of Antibiotic Stewardship Program. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase |
Assessment | |
Primary outcomes | Patient outcomes 30 days after discharge from ICU |
Key secondary outcomes | Patient outcome at the time of discharge from ICU, Antimicrobial Use Density (AUD), Days Of Therapy (DOT), the pattern of antimicrobial resistant bacteria and antimicrobial de-escalation rate. |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Purpose of intervention | |
Type of intervention | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients admitted to the ICU | |||
Key exclusion criteria | Patients who refuse to participate in the study | |||
Target sample size | 6000 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tokyo Medical and Dental University, Medical hospital | ||||||
Division name | Department of Intensive Care Medicine | ||||||
Zip code | 113-8519 | ||||||
Address | 1-5-45 Yushima Bunkyo-ku Tokyo | ||||||
TEL | 03-5803-5652 | ||||||
hshiccm@tmd.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Tokyo Medical and Dental University, Medical hospital | ||||||
Division name | Department of Intensive Care Medicine | ||||||
Zip code | 113-8519 | ||||||
Address | 1-5-45 Yushima Bunkyo-ku Tokyo | ||||||
TEL | 03-5803-5652 | ||||||
Homepage URL | |||||||
ykmishima.icu@tmd.ac.jp |
Sponsor | |
Institute | Department of Intensive Care Medicine, Tokyo Medical and Dental University |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Research Ethics Committee, Tokyo Medical and Dental University |
Address | 1-5-45 Yushima Bunkyo-ku Tokyo |
Tel | 03-3813-6111 |
syomu1.adm@tmd.ac.jp |
Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | M2019-055 |
Org. issuing International ID_1 | Research Ethics Committee, Tokyo Medical and Dental University |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 東京医科歯科大学医学部附属病院(東京都) |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Other | |
Other related information | Design: Before-After Study.
Participants: All ICU patients on the survey period. Survey Period: (1) Before launching Antimicrobial Stewardship Program: from April 2015 to September 2016. (2) After launching Multidisciplinary Rounds in ICU: from October 2016 to May 2018. (3) After launching "Time out": from June 2018 to March 2020. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043394 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |