UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000382 |
|---|---|
| Receipt number | R000000474 |
| Scientific Title | Phase II study of micafungin as empirical antifungal therapy for febrile neutropenic patients (C-SHOT 0503 study) |
| Date of disclosure of the study information | 2006/03/30 |
| Last modified on | 2013/11/23 19:18:13 |
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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
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/
gemi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Center for Supporting Hematology-Oncology Trials (C-SHOT)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000474
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| Registered date | File name |
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