Comparison of the Effect Between Levofloxacin and Moxifloxacin Among MDR-TB Patients
1 other identifier
interventional
182
1 country
29
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2010
Typical duration for phase_3
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2010
CompletedFirst Posted
Study publicly available on registry
January 25, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedNovember 27, 2012
November 1, 2012
2.3 years
January 21, 2010
November 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Negative conversion of M. tuberculosis
3 months after initiation of treatment
Study Arms (2)
levofloxacin
ACTIVE COMPARATORLevofloxacin 750mg po per day for 3 months
moxifloxacin
ACTIVE COMPARATORMoxifloxacin 400mg po per day for 3 months
Interventions
Levofloxacin 750mg po per day for 3 months vs. Moxifloxacin 400mg po per day for 3 months
Eligibility Criteria
You may qualify if:
- Patients with multidrug-resistant TB, but sensitive to levofloxacin and moxifloxacin
You may not qualify if:
- Achieved negative conversion of M. TB culture before the enrollment
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
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, 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
Related Publications (2)
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.
PMID: 26871879DERIVEDKoh 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.
PMID: 23927582DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae-Joon Yim, MD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 21, 2010
First Posted
January 25, 2010
Study Start
March 1, 2010
Primary Completion
July 1, 2012
Study Completion
October 1, 2012
Last Updated
November 27, 2012
Record last verified: 2012-11