UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000833 |
|---|---|
| Receipt number | R000001000 |
| Scientific Title | Blood Culture Contamination: Isopropyl alcohol compared with Isopropyl alcohol plus Povidone-Iodine as Skin Preparation before Blood Culture. |
| Date of disclosure of the study information | 2007/09/26 |
| Last modified on | 2008/03/30 21:54:47 |
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Basic information
Public title
Blood Culture Contamination: Isopropyl alcohol compared with Isopropyl alcohol plus Povidone-Iodine as Skin Preparation before Blood Culture.
Acronym
Non-randomized clinical trial: Comparison of Two Antiseptic Preparations before Blood Culture
Scientific Title
Blood Culture Contamination: Isopropyl alcohol compared with Isopropyl alcohol plus Povidone-Iodine as Skin Preparation before Blood Culture.
Scientific Title:Acronym
Non-randomized clinical trial: Comparison of Two Antiseptic Preparations before Blood Culture
Region
| Japan |
Condition
Condition
Bacteremia
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare the efficacies of two antiseptic preparations for skin in the prevention for contamination of blood culture. Thereby, we seek the optimal method of skin preparation before blood culture in a community-hospital setting in Japan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The blood culture contamination rate associated with each antiseptic at the end of five months period of this trial. Two blinded Infectious Disease physicians review positive cultures and classify them as true positive or as contamination based on chart's information.
Key secondary outcomes
Cost and time it takes to perform each antiseptic preparation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Skin antisepsis before blood culture is going to be performed with only 70% isopropyl alcohol on all patients above the age of 16 who visit Emergency Room.
Interventions/Control_2
Skin antisepsis before blood culture is going to be performed with 70% isopropyl alcohol plus povidone-iodine on all patiens above the age of 16 who are admitted in wards.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients suspected to be bacteremic above the age of 16.
Key exclusion criteria
All patients below the age of 15.
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Endo |
Organization
Okinawa Chubu Hospital
Division name
Internal Medicine
Zip code
Address
Miyazato281, Uruma city, Okinawa prefecture, Japan
TEL
098-973-4111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonori Kiyoyama |
Organization
Okinawa Chubu Hospital
Division name
Internal Medicine
Zip code
Address
Miyazato281, Uruma city, Okinawa prefecture, Japan
TEL
098-973-4111
Homepage URL
kiyoyama-tky@umin.ac.jp
Sponsor or person
Institute
Division of Internal Medicine, Okinawa Chubu Hospital
Institute
Department
Personal name
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
Address
Tel
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
| 2007 | Year | 09 | 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
Completed
Date of protocol fixation
| 2007 | Year | 09 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 09 | Month | 24 | Day |
Last modified on
| 2008 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001000
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| Registered date | File name |
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| Registered date | File name |
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