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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000008094
Receipt No. 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

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Basic information
Public title Clinical research on the multi drug theray including LVFX against tuberculosis
Acronym research on treatment including LVFX against TB
Scientific Title Clinical research on the multi drug theray including LVFX against tuberculosis
Scientific Title:Acronym research on treatment including LVFX against TB
Region
Japan

Condition
Condition lung tuberculosis
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of multi drug treatment including LVFX against tuberculerculosis that is difficult to treat
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 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)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Tuberculosis patients who are thought to be expected to use multi drug therapy including LVFX against tuberculosis for 6 months or longer
Key exclusion criteria resistant tu LVFX or OFLX
patients who are contraindicated to Cravit&reg;
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Yoshiyama
Organization Research institute of tuberculosis
Ryoken
Division name Department of research
Zip code
Address 3-1-24 Matsuyama Kiyose Tokyo, Japan
TEL 81-42-493-5711
Email yoshiyama@jata.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Yoshiyama
Organization Research Institute of Tuberculosis
Division name Department of research
Zip code
Address 3-1-24 Matsuyama Kiyose Tokyo, Japan
TEL 81-42-493-5711
Homepage URL
Email ryoken@jata.or.jp

Sponsor
Institute Ryoken
Institute
Department

Funding Source
Organization Kosei Kagaku (ministry of health, labor and welfare)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

IRB Contact (For public release)
Organization
Address
Tel
Email

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 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)

Other administrative information
Date of disclosure of the study information
2012 Year 06 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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.
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 Main results already published
Date of protocol fixation
2010 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2013 Year 05 Month 01 Day
Date of closure to data entry
2013 Year 05 Month 01 Day
Date trial data considered complete
2013 Year 05 Month 01 Day
Date analysis concluded
2013 Year 12 Month 01 Day

Other
Other related information was published on Kekkaku (Kekkaku 89;643-648:2014).

Management information
Registered date
2012 Year 06 Month 04 Day
Last modified on
2014 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008369

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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