UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006106 |
|---|---|
| Receipt number | R000007227 |
| Scientific Title | Comparison study of liposomal amphotericin B and micafungin in treatment of deep candidasis in surgical and emergency domains |
| Date of disclosure of the study information | 2011/08/03 |
| Last modified on | 2015/09/29 14:00:25 |
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Basic information
Public title
Comparison study of liposomal amphotericin B and micafungin in treatment of deep candidasis in surgical and emergency domains
Acronym
Comparison study of liposomal amphotericin B and micafungin in treatment of deep candidasis in surgical and emergency domains
Scientific Title
Comparison study of liposomal amphotericin B and micafungin in treatment of deep candidasis in surgical and emergency domains
Scientific Title:Acronym
Comparison study of liposomal amphotericin B and micafungin in treatment of deep candidasis in surgical and emergency domains
Region
| Japan |
Condition
Condition
Invasive Candidiasis
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Cardiology |
| Pneumology | Endocrinology and Metabolism | Nephrology |
| Neurology | Clinical immunology | Infectious disease |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Ophthalmology |
| Dermatology | Oto-rhino-laryngology | Urology |
| Anesthesiology | Neurosurgery | Cardiovascular surgery |
| Plastic surgery | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
"Guideline for the Diagnosis and Treatment of Deep Mycosis 2007" in Japan and "Clinical Practice Guidelines for the Management of Candidiasis: 2009 Update by the Infectious Diseases Society of America" 2 in the United States have been recently presented for diagnosis and treatment of deep candidiasis and recommend micafungin and liposomal amphotericin B as initial therapy for patients with invasive candidiasis. The clinical usefulness of L-AMB and MCFG on such deep candidiasis is studied.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Clinical effect (efficacy ratio) at the end or discontinuation of administration
Clinical symptoms between 4 and 7 days after the start of administration
Clinical symptoms between 5 and 10 days after the end of administration
Key secondary outcomes
Mycological effect
Serological effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
L-AMB group
The recommended dose is 2.5-5.0 mg/kg body weight administered intravenously over 1-3 hours once a day.
Depending on the patient condition, the dose can be increased or decreased within a range of up to 5.0 mg once a day as appropriate (the treatment can be even discontinued).
Interventions/Control_2
MCFG group
The recommended dose is 150 mg administered intravenously over one hour once a day.
The dose can be increased up to 300 mg once a day in patients with severe candidiasis.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient with Invasive Candidiasis or Suspected Invasive Candidiasis
Key exclusion criteria
(1) Cases treated with L-AMB or MCFG of those enrolled in this study.
(2) Patients with a history of hypersensitivity to the ingredients of this product, such as shock
(3) Children (younger than 16 years old)
(4) Patients undergoing treatment (leukocyte transfusion) that is contraindicated for use in combination with L-AMB.
(5)Pregnant or lactating patients or possibly pregnant patients.
(6)Patients with a present illness of serious liver diseases not caused by infections or a past history of them.
(7) Patients with neutrophil counts of <500 cells/mm3.
(8)Patients with serious underlying diseases or infections who are not expected to live throughout the study period.
(9) Other patients judged to be unsuitable as subjects by the physicians in charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuka Yamagishi |
Organization
Aichi Medical University Hospital
Division name
Department of Infection Control and Prevention
Zip code
Address
1-1 Yazakokarimata,Nagakute,Aichi,480-1195, Japan
TEL
0561-62-3311
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Yamagishi |
Organization
Aichi Medical University Hospital
Division name
Department of Infection Control and Prevention
Zip code
Address
1-1 Yazakokarimata,Nagakute,Aichi,480-1195, Japan
TEL
0561-62-3311
Homepage URL
yymgs@aichi-med-u.ac.jp
Sponsor or person
Institute
Department of Infection Control and Prevention, Aichi Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
中濃厚生病院（岐阜県）、京都第二赤十字病院（京都府）、京都桂病院（京都府）、関西医科大学附属枚方病院（大阪府）、倉敷中央病院（岡山県）、川崎医科大学（岡山県）、鹿児島市医師会病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 03 | 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
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 03 | Day |
Last modified on
| 2015 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007227
