Won-Jung Koh^1*, Seung Heon Lee^2*, Young Ae Kang³, Chang-Hoon Lee⁴, Jae Chol Choi⁵, Jae Ho Lee⁶, Seung Hun Jang⁷, Kwang Ha Yoo⁸, Ki Hwan Jung², Ki Uk Kim⁹, Sang Bong Choi¹⁰, Yon Ju Ryu¹¹, Kyung Chan Kim¹², Soojung Um¹³, Yong Soo Kwon¹⁴, Yee Hyung Kim¹⁵, Won-Il Choi¹⁶, Kyeongman Jeon¹, Yong Il Hwang⁷, Se Joong Kim², Young Seok Lee¹⁷, Eun Young Heo⁴, Juhee Lee¹⁸, Yeo Woon Ki¹⁹, Tae Sun Shim²⁰, and Jae-Joon Yim¹⁹

¹Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
²Division of Pulmonary, Sleep and Critical Care Medicine, Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Gyeonggi-do, Republic of Korea
³Division of Pulmonology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea
⁴Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Republic of Korea
⁵Department of Internal Medicine, Chung-Ang University School of Medicine, Seoul, Republic of Korea
⁶Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Republic of Korea
⁷Division of Pulmonary, Allergy and Critical Care Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Gyeonggi-do, Republic of Korea
⁸Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Republic of Korea
⁹Department of Internal Medicine, Pusan National University School of Medicine, Busan, Republic of Korea
¹⁰Department of Internal Medicine, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Republic of Korea
¹¹Division of Pulmonary and Critical Care Medicine, Department of Medicine, Ewha Medical Center and Ewha Medical Research Institute, Ewha Womans University School of Medicine, Mokdong Hospital, Seoul, Republic of Korea
¹²Department of Internal Medicine, Catholic University of Daegu Hospital, Daegu, Republic of Korea
¹³Department of Internal Medicine, Division of Respirology, Dong-A University Medical Center, Busan, Republic of Korea
¹⁴Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Republic of Korea
¹⁵Department of Pulmonary and Critical Care Medicine, Kyung Hee University Hospital at Gangdong, School of Medicine, Kyung Hee University, Seoul, Republic of Korea
¹⁶Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Republic of Korea
¹⁷Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Busan Paik Hospital Inje University College of Medicine, Busan, Republic of Korea
¹⁸Medical Research Collaborating Center and
¹⁹Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine, Seoul, Republic of Korea; and
²⁰Division of Pulmonary and Critical Care Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea

Abstract
Rationale: Levofloxacin (LFX) and moxifloxacin (MXF) are the two most frequently recommended fluoroquinolones for treatment of patients with multidrug-resistant tuberculosis (MDR-TB). However, studies comparing the effectiveness of LFX and MXF among patients with MDR-TB are lacking.

Objectives: To compare the effectiveness of LFX and MXF in terms of culture conversion after 3 months of treatment for MDR-TB.

Methods: In this prospective multicenter randomized open label trial, we randomly assigned 182 patients with MDR-TB (sensitive to LFX and MXF) to receive either LFX (750 mg/day; 90 patients) or MXF (400 mg/day; 92 patients) with a background drug regimen. The primary outcome was the proportion of patients who achieved sputum culture conversion at 3 months of treatment. Secondary outcomes were time to culture conversion and time to smear conversion, with data censored at 3 months, and the proportions of adverse drug reactions.

Measurements and Main Results: At 3 months of treatment, 68 (88.3%) of the 77 patients in the LFX group and 67 (90.5%) of the 74 in the MXF group showed conversion to negative sputum cultures (odds ratio for LFX compared with MXF, 0.78; 95% confidence interval, 0.27-2.20). Adverse drug reactions were reported in six patients (7.7%) in the LFX group and four (5.2%) in the MXF group (P = 0.75).

Conclusions: The choice of LFX or MXF for treatment of patients with MDR-TB may not affect sputum culture conversion at 3 months of treatment.

KEYWORDS: multidrug-resistant tuberculosis, fluoroquinolone, moxifloxacin, levofloxacin

Correspondence and requests for reprints should be addressed to Jae-Joon Yim, M.D., Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine and Lung Institute, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, Republic of Korea.
^*W.-J.K. and S.H.L. contributed equally to this work.