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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000382 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | Febrile neutropenia | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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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 |
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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 |
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Date of IRB | |||||||
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |