Unique ID issued by UMIN | UMIN000003318 |
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Receipt number | R000004018 |
Scientific Title | The evaluation of clinical trial for the rapid diagnosis of influenza AH1pdm |
Date of disclosure of the study information | 2010/03/12 |
Last modified on | 2010/03/12 09:06:10 |
The evaluation of clinical trial for the rapid diagnosis of influenza AH1pdm
Clinical trial of rapid diagnosis of influenza AH1pdm
The evaluation of clinical trial for the rapid diagnosis of influenza AH1pdm
Clinical trial of rapid diagnosis of influenza AH1pdm
Japan |
Influenza
Infectious disease |
Others
NO
Multicenter prospective evaluation of a rapid diagnosis kit based on an immunochromatographic assay specifically detecting pandemic H1N1 (2009) influenza virus.
Efficacy
Confirmatory
Pragmatic
Not applicable
Sensitivity and specificity in comparison with the real-time RT-PCR method
Observational
Not applicable |
Not applicable |
Male and Female
The patient applicable to the following items
1) The patient whose body temperature is more than 38 degrees C
2) The patient who has one or more items of the following clinical condition
a. Headache
b. Joint pain
c. Muscular pain
d. Cough
e. Pain of a throat
f. Nasal mucus
g. Constitutional symptoms, such as a strong feeling of worthlessness
3) The patient considered that inspection by an influenza rapid diagnostic kit is required
4) The patient who has agreed with the participation to this clinical trial
The patient applicable to the following items
1. The patient who took anti-influenza medicine (Symmetrel, TAMIFURU, RIRENZA, etc.) within one week
2. The patient who has participated in other clinical trials
3. The patient judged to be unsuitable by the doctor
450
1st name | |
Middle name | |
Last name | Kenji Narahara |
MIZUHO MEDY Co., Ltd.
R&D Department
5-4 Fujinoki-Machi, Tosu City, Saga 841-0048 Japan
0942-85-0303
1st name | |
Middle name | |
Last name | Tadashi Imamura |
MIZUHO MEDY Co., Ltd.
Corporate Development Department
5-4 Fujinoki-Machi, Tosu City, Saga 841-0048 Japan
0942-85-0301
t-imamura@mizuho-m.co.jp
MIZUHO MEDY Co., Ltd.
MIZUHO MEDY Co., Ltd.
Profit organization
Japan
NO
国立国際医療センター戸山病院(東京都)、宮崎大学医学部附属病院(宮崎県)、県立宮崎病院(宮崎県)、市立小児診療所(宮崎県)、夜間急病センター(宮崎県)、千葉大学付属病院(千葉県)、帝京大学ちば総合医療センター(千葉県)、成田赤十字病院(千葉県)、鎗田病院(千葉県)
2010 | Year | 03 | Month | 12 | Day |
Unpublished
Completed
2009 | Year | 11 | Month | 04 | Day |
2010 | Year | 03 | Month | 01 | Day |
prospective
2010 | Year | 03 | Month | 12 | Day |
2010 | Year | 03 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004018
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