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

Email



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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name