Comparison of the Effect Between Levofloxacin and Moxifloxacin Among MDR-TB Patients
NCT ID: NCT01055145
Last Updated: 2012-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
182 participants
INTERVENTIONAL
2010-03-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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levofloxacin
Levofloxacin 750mg po per day for 3 months
levofloxacin, moxifloxacin
Levofloxacin 750mg po per day for 3 months vs. Moxifloxacin 400mg po per day for 3 months
moxifloxacin
Moxifloxacin 400mg po per day for 3 months
levofloxacin, moxifloxacin
Levofloxacin 750mg po per day for 3 months vs. Moxifloxacin 400mg po per day for 3 months
Interventions
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levofloxacin, moxifloxacin
Levofloxacin 750mg po per day for 3 months vs. Moxifloxacin 400mg po per day for 3 months
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Positive anti-HIV antibody
* Pregnant women or sexually active women without using proper birth control method
* Serum creatine grater than 2mg/dL, or urine protein greater than 2+
* Serum total bilirubin greater than 2 mg/dL or AST and ALT greater than 1.5 times of normal upper limit
* History or current arrhythmia
* Hypersensitivity to levofloxacin, moxifloxacin,or rifabutin
* Should use drug containing metal-ion, warfarin, phenytoin, theophylline, probenecid regularly
20 Years
75 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Seoul National University Hospital
Principal Investigators
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Jae-Joon Yim, MD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Catholic University of Korea Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
Bundang CHA Hospital
Bundang, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Bundang, Gyeonggi-do, South Korea
Hallym University Sacred Heart Hospital
Pyeongchon, Gyeonggi-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Seoul National University Hospital
Seoul, Seoul, South Korea
Kangwon National University Hospital
Chuncheon, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Gachon University Gil Hospital
Incheon, , South Korea
Gyeongsang National University Hospital
Jinju, , South Korea
Masan Samsung Medical Center
Masan, , South Korea
Inje University Pusan Paik Hospital
Pusan, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Asan Medical Center
Seoul, , South Korea
Chung-Ang University Yong-san Hospital
Seoul, , South Korea
East-West Neo Medical Center
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Inje University Sanggye Paik Hospital
Seoul, , South Korea
Kangbuk Samsung Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Korean Institute of Tuberculosis
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul Medical Center
Seoul, , South Korea
Seoul National University Boramae Medical Center
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Countries
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References
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Kang YA, Shim TS, Koh WJ, Lee SH, Lee CH, Choi JC, Lee JH, Jang SH, Yoo KH, Jung KH, Kim KU, Choi SB, Ryu YJ, Kim KC, Um S, Kwon YS, Kim YH, Choi WI, Jeon K, Hwang YI, Kim SJ, Lee HK, Heo E, Yim JJ. Choice between Levofloxacin and Moxifloxacin and Multidrug-Resistant Tuberculosis Treatment Outcomes. Ann Am Thorac Soc. 2016 Mar;13(3):364-70. doi: 10.1513/AnnalsATS.201510-690BC.
Koh WJ, Lee SH, Kang YA, Lee CH, Choi JC, Lee JH, Jang SH, Yoo KH, Jung KH, Kim KU, Choi SB, Ryu YJ, Chan Kim K, Um S, Kwon YS, Kim YH, Choi WI, Jeon K, Hwang YI, Kim SJ, Lee YS, Heo EY, Lee J, Ki YW, Shim TS, Yim JJ. Comparison of levofloxacin versus moxifloxacin for multidrug-resistant tuberculosis. Am J Respir Crit Care Med. 2013 Oct 1;188(7):858-64. doi: 10.1164/rccm.201303-0604OC.
Other Identifiers
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H-0911-068-301
Identifier Type: -
Identifier Source: org_study_id