Comparison of the Effect Between Levofloxacin and Moxifloxacin Among MDR-TB Patients
- Registration Number
- NCT01055145
- Lead Sponsor
- Seoul National University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 182
- Patients with multidrug-resistant TB, but sensitive to levofloxacin and moxifloxacin
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description moxifloxacin levofloxacin, moxifloxacin Moxifloxacin 400mg po per day for 3 months levofloxacin levofloxacin, moxifloxacin Levofloxacin 750mg po per day for 3 months
- Primary Outcome Measures
Name Time Method Negative conversion of M. tuberculosis 3 months after initiation of treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Inje University Pusan Paik Hospital
🇰🇷Pusan, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Kangwon National University Hospital
🇰🇷Chuncheon, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Cheongju, Chungbuk, Korea, Republic of
Bundang CHA Hospital
🇰🇷Bundang, Gyeonggi, Korea, Republic of
Catholic University of Korea Bucheon St. Mary's Hospital
🇰🇷Bucheon, Gyeonggi, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Bundang, Gyeonggi, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan, Gyeonggi, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Pyeongchon, Gyeonggi, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju, Korea, Republic of
Gachon University Gil Hospital
🇰🇷Incheon, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Inje University Sanggye Paik Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Korean Institute of Tuberculosis
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Yong-san Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
East-West Neo Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Masan Samsung Medical Center
🇰🇷Masan, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Seoul Medical Center
🇰🇷Seoul, Korea, Republic of