UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042343 |
|---|---|
| Receipt number | R000048323 |
| Scientific Title | The effectiveness of Antiseptic solution for Prevention of intravenous catheter-related blood stream infection with OLanexidine glucOnate |
| Date of disclosure of the study information | 2020/11/05 |
| Last modified on | 2023/05/08 17:36:58 |
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Basic information
Public title
Efficacy of oranexidine gluconate in the prevention of catheter-related bloodstream infections
Acronym
Apollo study
Scientific Title
The effectiveness of Antiseptic solution for Prevention of intravenous catheter-related blood stream infection with OLanexidine glucOnate
Scientific Title:Acronym
Apollo study
Region
| Japan |
Condition
Condition
Patients 18 years of age or older admitted to the ICU or HCU with a newly inserted central venous catheter or hemodialysis catheter
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the non-inferiority of 1.5% olanexidine gluconate solution to 1% chlorhexidine alcohol in the occurrence of catheter-related bloodstream infections.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Incidence of catheter-related infections
Key secondary outcomes
1) Incidence of catheter-related infections (per 1000 catheters/day)
2) In-hospital mortality rate
3) ICU mortality rate
4) Incidence of resistant bacteria (MRSA, Pseudomonas aeruginosa, VRE)
5) Adverse events (redness, urticaria, anaphylaxis, contact dermatitis etc.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Intervention: 1.5% Oranexidine gluconate solution (Otsuka Pharmaceutical Factory, Inc.)
Interventions/Control_2
Control: 1% chlorhexidine alcohol (Toho Yakuhin Co.,Ltd)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients 18 years of age or older admitted to the ICU or HCU with newly inserted central venous or hemodialysis catheters.
Key exclusion criteria
1) Patients with allergies to disinfectants
2) When the consent of the subject or his or her next of kin cannot be obtained
3) Patients with systemic skin diseases
4) The presence of a wound skin ulcer
5) When the catheter is replaced under the guidewire
6) Patients with antimicrobial catheters
7) Patients with antimicrobial-containing dressings
8) Patients participating in intervention trials related to CRBSI prevention (e.g., dressings, skin disinfectants, antimicrobial catheters, antimicrobial medications, etc.)
9) When it is judged to be difficult to obtain consent due to an emergency, etc.
Target sample size
1980
Research contact person
Name of lead principal investigator
| 1st name | Hideto |
| Middle name | |
| Last name | Yasuda |
Organization
Jichi Medical University Saitama Medical Center
Division name
Department of Emergency and Critical Care Medicine
Zip code
330-8503
Address
1-847, Amanuma-cho, Oomiya-ku, Saitama-shi, Saitama, 330-8503, Japan
TEL
048-647-2111
yasudahideto@me.com
Public contact
Name of contact person
| 1st name | Hideto |
| Middle name | |
| Last name | Yasuda |
Organization
Jichi Medical University Saitama Medical Center
Division name
Department of Emergency and Critical Care Medicine
Zip code
Jichi Medical University Saitama Medical Center
Address
1-847, Amanuma-cho, Oomiya-ku, Saitama-shi, Saitama, 330-8503, Japan
TEL
048-647-2111
Homepage URL
yasudahideto@me.com
Sponsor or person
Institute
Jichi Medical University Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Japanese Association for Acute Medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Clinical Trial, Jichi Medical University Saitama Medical Center
Address
1-847, Amanuma-cho, Oomiya-ku, Saitama-shi, Saitama, 330-8503, Japan
Tel
048-647-2111
s-suishin@jichi.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 | 11 | Month | 05 | 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
The data of this study will not be shared without the approval of the members of this study. If all members of this study agree with sharing the data of this study, all data will be shared with anyone who applied for data sharing.
IPD sharing Plan description
Will individual participant data be available? : Yes
What data in particular will be shared? : All of the individual participant data collected during the trial, after deidentification.
What other documents will be available? : Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code.
When will data be available? : Immediately following publication. No end date.
With whom? : Anyone who wishes to access the data.
For what types of analyses? : Any purpose.
By what mechanism will data be made available? : Proposals should be directed to yasudahideto@me.com.
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 04 | Day |
Last modified on
| 2023 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048323
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
