UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of micafungin as empirical antifungal therapy for febrile neutropenic patients (C-SHOT 0503 study)
Acronym	Phase II study of micafungin as empirical antifungal therapy for febrile neutropenic patients (C-SHOT 0503 study)
Scientific Title	Phase II study of micafungin as empirical antifungal therapy for febrile neutropenic patients (C-SHOT 0503 study)
Scientific Title:Acronym	Phase II study of micafungin as empirical antifungal therapy for febrile neutropenic patients (C-SHOT 0503 study)
Region	Japan

Condition
Condition	Febrile neutropenia
Classification by specialty	Hematology and clinical oncology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The major objective of this study is to evaluate efficacy and feasibility of empirical antifungal therapy with micafungin for patients with febrile neutropenia unresponsive to antibacterial agents.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Rate of treatment success as defined by a 4-component composite endpoint (defervescence, development of breakthrough fungal infections, discontinuation of the study drug, and death)
Key secondary outcomes	Incidence of adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Micafungin intravenously over 1 hour at a daily dose of 150 mg
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Hematologic disease; (2) Age between 15 and 79; (3) Axillary temperature of 38.0 C or greater; (4) Absolute neutrophil count of less than 500/microL; (5) Persistent or recurrent fever after at least 96 hours of antibacterial therapy; (6) T-Bil level less than 2.0 times the upper limit of normal; (7) Cre level less than 1.5 times the upper limit of normal; (8) Written informed consent
Key exclusion criteria	(1) Past history of allergic reaction to the study drug; (2) MIcrobiological documented infection; (3) Having received systemic antifungal of antiviral therapy within 14 days; (4) Septic shock; (5) Allogeneic transplantation; (6) Body weight of less than 25 kg; (7) Positive for HIV antibody; (8) Pregnant or lactating woman
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomoki Naoe
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Hematology and Oncology
Zip code
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2145
Email

Public contact
Name of contact person	1st name Middle name Last name Emi Goto
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Hematology and Oncology
Zip code
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2145
Homepage URL	http://www.c-shot.or.jp/
Email	gemi@med.nagoya-u.ac.jp

Sponsor
Institute	Center for Supporting Hematology-Oncology Trials (C-SHOT)
Institute
Department

Funding Source
Organization	Astellas Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2006 Year 03 Month 30 Day

Related information
URL releasing protocol	http://www.c-shot.or.jp/
Publication of results	Published

Result
URL related to results and publications	http://www.ncbi.nlm.nih.gov/pubmed/23857638
Number of participants that the trial has enrolled
Results	Of the 78 evaluable patients, 54 (69 %) achieved defervescence by the time of neutrophil recovery, and 56 (72 %) completed the treatment in accordance with the provision of the protocol. Four patients developed invasive fungal infection, nine changed antifungal therapy because of lack of efficacy, and three discontinued micafungin because of drug-related adverse events. Based on the composite end point taking account of these, the overall treatment success rate was 60 %, with the lower limit of a 90 % confidence interval (50.3 %) exceeding the predefined threshold success rate (50 %).
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	2006 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date	2006 Year 04 Month 01 Day
Last follow-up date	2010 Year 02 Month 01 Day
Date of closure to data entry	2010 Year 05 Month 01 Day
Date trial data considered complete	2010 Year 06 Month 01 Day
Date analysis concluded	2010 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date	2006 Year 03 Month 30 Day
Last modified on	2013 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000474

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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