UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021723 |
|---|---|
| Receipt number | R000025055 |
| Scientific Title | Reduction of antibiotic treatment initiation events by replacing regular textiles with biocidal copper oxide impregnated textiles: crossover, double blind and placebo controlled clinical study |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2016/03/31 21:38:39 |
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Basic information
Public title
Reduction of antibiotic treatment initiation events by replacing regular textiles with biocidal copper oxide impregnated textiles: crossover, double blind and placebo controlled clinical study
Acronym
Reduction of nosocomial infection by using copper impregnated textiles
Scientific Title
Reduction of antibiotic treatment initiation events by replacing regular textiles with biocidal copper oxide impregnated textiles: crossover, double blind and placebo controlled clinical study
Scientific Title:Acronym
Reduction of nosocomial infection by using copper impregnated textiles
Region
| Asia(except Japan) |
Condition
Condition
prevention of nosocomial infections in long term care facilities
Classification by specialty
| Infectious disease | Geriatrics | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determine if replacing regular linens and patients' clothes with copper oxide biocidal textiles reduces antibiotic treatment initiation (ATI) events, fever days and antibiotic usage among chronic mechanically ventilated patients in a long-term care facility.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Antibiotic treatment initiation (ATI) events: a clinical presentation in which it was decided to administer antimicrobial therapy per 1000 hospitalization days during the study periods.
Key secondary outcomes
fever days: number of days during which the axillary temperature was above 37.6C per 1000 hospitalization days during the study periods.
Antibiotic usage: the number of days antibiotics were administrated per 1000 hospitalization days. The antibiotics defined daily dose (DDD) per 1000 patient days was calculated according to the WHO Collaborating Center for Drug Statistics Methodology guidelines, during the study periods.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
A double-blind cross-over study. During period I, one ward received copper oxide impregnated textiles (linen, patients clothes and towels), and the other received Control untreated textiles; in period III the ward that received the treated textiles received the control textiles and vis versa. During Period II both wards received usual textiles. The textiles were coded with different colors and the personal staff was blinded to which were the treated or control textiles. There were no differences in the nosocomial prevention measures implemented in the wards during the study.
Interventions/Control_2
A double-blind cross-over study. During period I, one ward received copper oxide impregnated textiles (linen, patients clothes and towels), and the other received Control untreated textiles; in period III the ward that received the treated textiles received the control textiles and vis versa. During Period II both wards received usual textiles. The textiles were coded with different colors and the personal staff was blinded to which were the treated or control textiles. There were no differences in the nosocomial prevention measures implemented in the wards during the study.
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
All patients in the wards
Key exclusion criteria
no exclusion
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dr. Esther-Lee Marcus |
Organization
Herzog Hospital
Division name
Chronic Ventilator Dependent Unit
Zip code
Address
Givat Shaul Street POB 3900, Jerusalem 91035, Israel
TEL
972-508288188
estherlee@herzoghospital.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dr. Gadi Borkow |
Organization
Cupron Inc.
Division name
Cupron Scientific
Zip code
Address
Hameyasdim 44, Gibton 76910
TEL
972-546611287
Homepage URL
http://www.cupron.com
gadi@cupron.com
Sponsor or person
Institute
Herzog Hospital
Institute
Department
Personal name
Funding Source
Organization
Cupron Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
USA
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
Chronic Ventilator Dependent Unit, Herzog Hospital, Jerusalem, Israel; Affiliated to Hadassah Hebrew University, Faculty of Mecine
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 31 | 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
There were 29.1% (p=0.002), 55.5% (p<0.0001), 23% (p<0.0001) and 29.2% (p<0.001) relative reductions in the antibiotic treatment initiation (ATI) events, days of fever, days of antibiotic treatments and antibiotics defined daily dose (DDD) per 1000 hospitalization days (HD), respectively, that occurred when using the copper impregnated textiles. In one ward there were 25.6% (p=0.093), 49.8% (p<0.0001), 18% (p=0.003) and 19.5% (p<0.001) and in the second ward 56.8% (p=0.07), 65% (p<0.0001), 30.4% (p<0.0001) and 41.53%, relative reductions in ATI events, fever days, days of antibiotic administration, and DDD per 1000 HD, respectively, when using the treated textiles compared to when using the untreated textiles.
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
Terminated
Date of protocol fixation
| 2014 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 31 | Day |
Last modified on
| 2016 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025055
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