Unique ID issued by UMIN | UMIN000012243 |
---|---|
Receipt number | 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 12:31:54 |
Safety and efficacy of extended pyrazinamide (PZA) administration for prolonged smear positive pulmonary tuberculosis
Safety and efficacy of extended pyrazinamide (PZA) administration for prolonged smear positive pulmonary tuberculosis
Safety and efficacy of extended pyrazinamide (PZA) administration for prolonged smear positive pulmonary tuberculosis
Safety and efficacy of extended pyrazinamide (PZA) administration for prolonged smear positive pulmonary tuberculosis
Japan |
pulmonary tuberculosis
Pneumology |
Others
NO
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
Safety,Efficacy
Confirmatory
Pragmatic
Days to culture conversion (ITT analysis)
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Continue intensive antituberculous therapy until culture conversion up to 16 weeeks, followed by INH/RFP for total 9 months
20 | years-old | <= |
85 | years-old | > |
Male and Female
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 – 8th weeks
5)Written informed concent
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
40
1st name | |
Middle name | |
Last name | Jin Takasaki |
National Center for Global Health and Medicine
Department of Respiratory Medicine
1-21-1, Toyama, Shinnjuku-ku, Tokyo, Japan
03-3202-7181
jintakajj@gmail.com
1st name | |
Middle name | |
Last name | Jin Takasaki |
National Center for Global Health and Medicine
Department of Respiratory Medicine
1-21-1, Toyama, Shinnjuku-ku, Tokyo, Japan
03-3202-7181
jintakajj@gmail.com
National Center for Global Health and Medicine
The grant of National center for Global Health and Medicine
Other
NO
2013 | Year | 11 | Month | 08 | Day |
Unpublished
Terminated
2012 | Year | 06 | Month | 29 | Day |
2012 | Year | 08 | Month | 30 | Day |
2013 | Year | 11 | Month | 08 | Day |
2013 | Year | 11 | Month | 08 | Day |
Value
https://center6.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 |