Unique ID issued by UMIN | UMIN000003185 |
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Receipt number | R000003849 |
Scientific Title | Phase II study of liposomal amphotericin B for febrile neutropenia.(C-SHOT1001) |
Date of disclosure of the study information | 2010/02/15 |
Last modified on | 2016/11/02 10:47:18 |
Phase II study of liposomal amphotericin B for febrile neutropenia.(C-SHOT1001)
L-AMB for FN.(C-SHOT1001)
Phase II study of liposomal amphotericin B for febrile neutropenia.(C-SHOT1001)
L-AMB for FN.(C-SHOT1001)
Japan |
Hematological malignancies
Hematology and clinical oncology |
Malignancy
NO
To make clear the effectiveness of empirical therapy of L-AMB for febrile neutropenia in patients with haematological malignancies.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
*Keeping up body temperature under 38degrees celcius for 48 hours.
*No invasive fungal infection
*No change of antifungal agents
*No interruption of treatment due to adverse reactions
*Patient survival
*Frequencies of adverse reactions
*Alleviation of fever
*The therapy finished.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Empirical therapy of L-AMB
16 | years-old | <= |
80 | years-old | > |
Male and Female
Patients with haematological malignancies accompanied by febrile neutropenia who do not respond to antibiotics.
Age ranging from 16 to 79.
(1) Allergy to L-AMB
(2) Infection with proven pathogens
(3) HIV-antibody positive
(4) Pregnant or lactating patients
(5) Patients after allogeneic stem cell transplantation
(6) Invasive fungal infections
(7) Those considered inappropriate to be participated
80
1st name | |
Middle name | |
Last name | Nobuhiko Emi |
Fujita Health University
Department of Hematology
1-9-8 Dengakugakubo Kutsukake-cho Toyoake Aichi
0562-93-2000
1st name | |
Middle name | |
Last name | Masashi Sawa |
Anjo Kosei Hospital
Department hematology and oncology
28 Higashihirokute Anjo-cho Anjo Aichi
0566-75-2111
support@c-shot.or.jp
Center for Supporting Hematology-Oncology Trials
Center for Supporting Hematology-Oncology Trials
Non profit foundation
NO
2010 | Year | 02 | Month | 15 | Day |
Unpublished
Completed
2010 | Year | 03 | Month | 11 | Day |
2010 | Year | 04 | Month | 01 | Day |
2010 | Year | 02 | Month | 15 | Day |
2016 | Year | 11 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003849
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