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Fluoroquinolone is a one of the most important drugs for treatment of multidrug-resistant TB (MDR-TB). Among them, levofloxacin and moxifloxacin has been used most widely. However, there is no study to directly compare the efficacy of levofloxacin and moxifloxacin among MDR-TB patients. The investigators will compare the efficacy of levofloxacin and moxifloxacin through a prospective multicenter randomized open label phase III trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| levofloxacin | Active Comparator | Levofloxacin 750mg po per day for 3 months |
|
| moxifloxacin | Active Comparator | Moxifloxacin 400mg po per day for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levofloxacin, moxifloxacin | Drug | Levofloxacin 750mg po per day for 3 months vs. Moxifloxacin 400mg po per day for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Negative conversion of M. tuberculosis | 3 months after initiation of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Joon Yim, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Ansan | Gyeonggi-do | South Korea | |||
| Catholic University of Korea Bucheon St. Mary's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26871879 | Derived | 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. | |
| 23927582 |
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| 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 | 110-744 | 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 |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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