UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036933 |
|---|---|
| Receipt number | R000041931 |
| Scientific Title | Investigating the tissue migration of anti-MRSA drugs in soft tissue infections |
| Date of disclosure of the study information | 2019/06/04 |
| Last modified on | 2022/06/06 10:47:26 |
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Basic information
Public title
Investigating the tissue migration of
anti-MRSA drugs in soft tissue infections
Acronym
Investigating the tissue migration of
anti-MRSA drugs in soft tissue infections
Scientific Title
Investigating the tissue migration of
anti-MRSA drugs in soft tissue infections
Scientific Title:Acronym
Investigating the tissue migration of
anti-MRSA drugs in soft tissue infections
Region
| Japan |
Condition
Condition
Pressure ulcer in sacral and ischial region which have been performed flap reconstruction.
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare the concentration of the anti MRSA medicine in the tissue fluid and the blood. We Investigate the tissue migration of anti-MRSA drugs in soft tissue infections
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concentration of the anti MRSA medicine in the tissue fluid, the blood plasma and tissue transitivity of the medicine, We compare the concentration using the fluid in the drainage bag and the data of blood test until 3days post operation date.
Key secondary outcomes
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
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A total of 60 patients with bed sores who were eligible for flap formation and were infected or colonized by MRSA (patients receiving vancomycin, n = 20; those receiving daptomycin, n = 20; and those receiving linezolid, n = 20) were enrolled.
Key exclusion criteria
Patients aged under 15 years or over 100 years.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Sato |
Organization
Saitama Medical University Hospital
Division name
Plastic and Reconstructive surgery department
Zip code
3500495
Address
38 Morohongo, Moroyama, Iruma-Gun, Saitama prefecture, Japan
TEL
0492761230
tsato11032@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Sato |
Organization
Saitama Medical University Hospital
Division name
Plastic and Reconstructive surgery department
Zip code
3500495
Address
38 Morohongo, Moroyama, Iruma-Gun, Saitama prefecture, Japan
TEL
0492761230
Homepage URL
tsato11032@yahoo.co.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB executive office of Saitama Medical University hospital
Address
38 Morohongo, Moroyama, Iruma-Gun, Saitama prefecture, Japan
Tel
0492761354
hirb@saitama-med.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
| 2019 | Year | 06 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Sample collection
A subcutaneous drain was placed during surgery. Patients received an anti- MRSA drug (vancomycin, daptomycin, or linezolid) 30 min before the surgery and at 9 o'clock from the following day onward. A drainage sample (10ml) was collected on the day after surgery.
2. Determination of drug concentrations
The ratio of anti- MRSA drug concentrations in blood and drainage samples was calculated to determine the tissue migration of the drugs. Drug concentrations were determined using a liquid chromatography- tandem spectrometer (LC-MS/ MS).
Management information
Registered date
| 2019 | Year | 06 | Month | 03 | Day |
Last modified on
| 2022 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041931
| Research Plan | |
|---|---|
| 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 |
