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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030745
Receipt No. 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 2019/07/18

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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
Email 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
Email mochi-gif@umin.ac.jp

Sponsor
Institute Gifu University Graduate School of Medicine
Institute
Department

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
Email 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 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 Enrolling by invitation
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
2019 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035112

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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