UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030745 |
|---|---|
| Receipt number | R000035112 |
| Scientific Title | Tissue distribution after intravenous dosing of liposomal amphotericin B in deep-seated mycoses |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2021/10/05 07:46:39 |
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Basic information
Public title
Tissue distribution after intravenous dosing of liposomal amphotericin B in deep-seated mycoses
Acronym
Dstribution of liposomal amphotericin B
Scientific Title
Tissue distribution after intravenous dosing of liposomal amphotericin B in deep-seated mycoses
Scientific Title:Acronym
Dstribution of liposomal amphotericin B
Region
| Japan |
Condition
Condition
deep-seated mycoses
Classification by specialty
| Ophthalmology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the tissue distribution after intravenous dosing of liposomal amphotericin B in deep-seated mycoses
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the concentartion of L-AMB in tha plasma and tissues after the last intravenous injection
Key secondary outcomes
beta-D-glucan
isolated organism
drug susceptibility
visual acuity
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases of deep-seated mycoses or fungal endophthalmitis which were resistant to systemic L-AMB administration and required surgical treatment such as vitrectomy, or enucleation.
Key exclusion criteria
Cases in which patient consent was not obtained or the attending physician deemed invalid due to various reasons.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kiyofumi |
| Middle name | |
| Last name | Mochizuki |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
501-1194
Address
1-1 Yanagido, Gifu-shi 501-1194, Japan
TEL
058-230-6288
mochi-gif@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kiyofumi |
| Middle name | |
| Last name | Mochizuki |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
501-1194
Address
1-1 Yanagido, Gifu-shi 501-1194, Japan
TEL
058-230-6288
Homepage URL
mochi-gif@umin.ac.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Gifu University Graduate School of Medicine
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
Gifu University Graduate School of Medicine
Address
1-1 Yanagido, Gifu-shi 501-1194, Japan
Tel
058-230-6059
rinri@gifu-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
HS2017-246
Org. issuing International ID_1
Gunma University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
岐阜県総合医療センター(岐阜県)
大垣市民病院（岐阜県）
群馬大学医学部附属病院（群馬県）
岐阜市民病院（岐阜県）
同志社女子大学薬学部 臨床薬剤学教室（京都府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
5
Results
The amphotericin B level in the cornea exceeded the minimum inhibitory concentration, however the levels in the aqueous and vitreous humors were lower. Our findings indicate that intravenous L-AMB should be applied in combination with other intravitreal antifungal agents in cases of severe intraocular fungal diseases.
Results date posted
| 2021 | Year | 10 | Month | 05 | Day |
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
| 2014 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measure the concentration of L-AMB in blood and tissues and compare the MICs of isolated fungus. Analyse visual acuity before and after administration of L-AMB.
Management information
Registered date
| 2018 | Year | 01 | Month | 10 | Day |
Last modified on
| 2021 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035112
| 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 |
