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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012243
Receipt No. R000013986
Scientific Title Safety and efficacy of extended pyrazinamide (PZA) administration for prolonged smear positive pulmonary tuberculosis
Date of disclosure of the study information 2013/11/08
Last modified on 2013/11/08

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Basic information
Public title Safety and efficacy of extended pyrazinamide (PZA) administration for prolonged smear positive pulmonary tuberculosis
Acronym Safety and efficacy of extended pyrazinamide (PZA) administration for prolonged smear positive pulmonary tuberculosis
Scientific Title Safety and efficacy of extended pyrazinamide (PZA) administration for prolonged smear positive pulmonary tuberculosis
Scientific Title:Acronym Safety and efficacy of extended pyrazinamide (PZA) administration for prolonged smear positive pulmonary tuberculosis
Region
Japan

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

Objectives
Narrative objectives1 To investigate safety and efficacy of prolonged intensive phase treatment including long-term pyrazinamide administration (up to 4 months) for isoniazid (INH) and/or refampicin (RFP) susceptive severe pulmonary tuberculosis whose AFB smear is continuously positive at 8 weeks
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Days to culture conversion (ITT analysis)
Key secondary outcomes 1)days to culture convertion (PPS analysis)
2)incidence of adversed reaction
3)rate of treatment interuption
4)rate of culture conversion at 9 months

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Continue intensive antituberculous therapy until culture conversion up to 16 weeeks, followed by INH/RFP for total 9 months
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
85 years-old >
Gender Male and Female
Key inclusion criteria All of followings
1)Active, smear-positive pulmonary tuberculossis
2)Treated for 8 weeks of initial intensive phase without any untolerable harmful events
3)Smear positive for consecutive 3 times at 6th - 8th weeks of intensive phase, at least one of which was 2+ or 3+
4)Culture positive at least 2 times on 4th &#8211; 8th weeks
5)Written informed concent
Key exclusion criteria 1)HIV positive
2)Systemic corticosteroids or other imunosuppressants administration
3)Pregnancy or breast feeding
4)Resistance of INH and/or RFP
5)Hyperuricemia or past history of gout
6)Any laboratory abnormal finding as follows; T-bil >= 3.0 mg/dL, WBC < 2,000 /mm3, Hgb < 7.0 g/dL, or Plt < 50,000 /mm3
7)Others judjed to be unsuitable as subjects by the physicians in charge
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jin Takasaki
Organization National Center for Global Health and Medicine
Division name Department of Respiratory Medicine
Zip code
Address 1-21-1, Toyama, Shinnjuku-ku, Tokyo, Japan
TEL 03-3202-7181
Email jintakajj@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Jin Takasaki
Organization National Center for Global Health and Medicine
Division name Department of Respiratory Medicine
Zip code
Address 1-21-1, Toyama, Shinnjuku-ku, Tokyo, Japan
TEL 03-3202-7181
Homepage URL
Email jintakajj@gmail.com

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization The grant of National center for Global Health and Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Terminated
Date of protocol fixation
2012 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 08 Day
Last modified on
2013 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013986

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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