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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000011935 |
Receipt No. | R000013935 |
Scientific Title | Prevalence study of MRSA colonization and infection for patients at NICU ward |
Date of disclosure of the study information | 2013/10/02 |
Last modified on | 2015/12/07 |
Basic information | ||
Public title | Prevalence study of MRSA colonization and infection for patients at NICU ward | |
Acronym | MRSA prevalence study at NICU | |
Scientific Title | Prevalence study of MRSA colonization and infection for patients at NICU ward | |
Scientific Title:Acronym | MRSA prevalence study at NICU | |
Region |
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Condition | ||
Condition | MRSA infection | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Evaluation of the prevalence rate of MRSA colonization and infection for patients at NICU ward. |
Basic objectives2 | Others |
Basic objectives -Others | Evaluation of the clinical utility of MRSA screening at the hospitalization and hospital stay after hospitalization at NICU ward.
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Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Others |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | 1. Number and rate of MRSA import into NICU ward.
2. Number and rate of MRSA acquisition at NICU ward. |
Key secondary outcomes | 1. Concordance bwtween PCR and culture method for MRSA testing.
2. Clinical utility of MRSA PCR testing for the diagnosis of MRSA infection. |
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 | |
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Interventions/Control_6 | |
Interventions/Control_7 | |
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Interventions/Control_9 | |
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 at NICU ward. | |||
Key exclusion criteria | NA. | |||
Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Nagasaki University | ||||||
Division name | Department of Labolratory Medicine, Nagasaki University Graduate School of Biomedical Science | ||||||
Zip code | |||||||
Address | 1-7-1 Sakamoto, Nagasaki 852-8501, Japan | ||||||
TEL | 81-95-819-7574 | ||||||
k-yanagi@nagasaki-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Nagasaki University | ||||||
Division name | Department of Labolratory Medicine, Nagasaki University Graduate School of Biomedical Science | ||||||
Zip code | |||||||
Address | 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan | ||||||
TEL | 81-95-819-7574 | ||||||
Homepage URL | |||||||
y-morina@nagasaki-u.ac.jp |
Sponsor | |
Institute | Nagasaki University |
Institute | |
Department |
Funding Source | |
Organization | Nippon Becton Dickinson Company , Ltd. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
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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 |
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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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | NA |
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=R000013935 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |