UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008094
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

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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 or person

Institute

Ryoken

Institute

Department

Personal name



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

Value
https://center6.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