Unique ID issued by UMIN | UMIN000008094 |
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Receipt number | R000008369 |
Scientific Title | Clinical research on the multi drug theray including LVFX against tuberculosis |
Date of disclosure of the study information | 2012/06/04 |
Last modified on | 2014/07/15 20:13:03 |
Clinical research on the multi drug theray including LVFX against tuberculosis
research on treatment including LVFX against TB
Clinical research on the multi drug theray including LVFX against tuberculosis
research on treatment including LVFX against TB
Japan |
lung tuberculosis
Pneumology |
Others
NO
To evaluate the efficacy and safety of multi drug treatment including LVFX against tuberculerculosis that is difficult to treat
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
The efficacy is measured by the proportion of negative conversion of tuberculosis bacilli.
The safety is measured by the emergence of side effects (clinical findings and laboratory examination)
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Tuberculosis patients who are thought to be expected to use multi drug therapy including LVFX against tuberculosis for 6 months or longer
resistant tu LVFX or OFLX
patients who are contraindicated to Cravit®
200
1st name | |
Middle name | |
Last name | Takashi Yoshiyama |
Research institute of tuberculosis
Ryoken
Department of research
3-1-24 Matsuyama Kiyose Tokyo, Japan
81-42-493-5711
yoshiyama@jata.or.jp
1st name | |
Middle name | |
Last name | Takashi Yoshiyama |
Research Institute of Tuberculosis
Department of research
3-1-24 Matsuyama Kiyose Tokyo, Japan
81-42-493-5711
ryoken@jata.or.jp
Ryoken
Kosei Kagaku (ministry of health, labor and welfare)
Japan
none
none
NO
結核療法研究協議会参加施設
茨城東病院(茨城県)
東京病院(東京都)
多摩総合医療センター(東京都)
複十字病院(東京都)
富山病院(富山県)
松江医療センター(島根県)
東広島医療センター(広島県)
福岡東医療センター(福岡県)
西別府病院(大分県)
南九州病院(鹿児島県)
宮崎東病院(宮崎県)
道北病院(北海道)
岩手県立中央病院(北海道)
市立秋田総合病院(秋田県)
山形病院(山形県)
西群馬病院(群馬県)
結核予防会新山手病院(東京都)
川崎市立井田病院(神奈川県)
西新潟中央病院(新潟県)
まつもと医療センタ-中信松本病院(長野県)
天竜病院(静岡県)
大阪府立呼吸器・アレルギー医療センター(大阪府)
西神戸医療センター (兵庫県)
南岡山医療センター(岡山県)
愛媛病院(愛媛県)
北九州市立門司病院(福岡県)
医療法人西福岡病院(福岡県)
大牟田病院(福岡県)
沖縄病院(沖縄県)
2012 | Year | 06 | Month | 04 | Day |
Published
Background: Levofloxacin is used as an antibiotic, while its prospective safety study for the long term use has not been reported. This lack of information is a barrier to its use for the anti-tuberculosis drugs.
Method: Cases that used levofloxacin for a long term were prospectively followed up at hospitals that belonged to Ryoken. Proportions of adverse events are reported.
Results and discussion: Among 91 cases, 5 cases were reported to have adverse drug reactions that are or may be related to levofloxacin. Among these 5 cases, 4 cases reported arthralgia and muscle pain and these events occurred 490 to 157 days after starting levofloxacin. Life table analysis using Kaplan Mayer method revealed the adverse drug reaction free proportion of 93.5% at 180 days. Among 49 bacillary positive cases, 1 case died one month later, one case was without culture examination and 47 cases showed culture conversion.
Conclusion: Levofloxacin is thought to be used safely for a long term but arthralgia needs to be checked for long users.
Main results already published
2010 | Year | 07 | Month | 15 | Day |
2010 | Year | 08 | Month | 01 | Day |
2013 | Year | 05 | Month | 01 | Day |
2013 | Year | 05 | Month | 01 | Day |
2013 | Year | 05 | Month | 01 | Day |
2013 | Year | 12 | Month | 01 | Day |
was published on Kekkaku (Kekkaku 89;643-648:2014).
2012 | Year | 06 | Month | 04 | Day |
2014 | Year | 07 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008369
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