Clinical trial NCT01055145: Comparison of the Effect Between Levofloxacin and Moxifloxacin Among MDR-TB Patients
Official title: Comparison of the Effect Between Levofloxacin and Moxifloxacin on the Culture Conversion After 3 Months Treatment Among MDR-TB Patients; Prospective Multicenter Randomized Open Label Phase III Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: TB
Keywords: Multidrug-resistant TB, sensitive to levofloxacin and moxifloxacin
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-01-25
Enrollment: 182
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Patients with multidrug-resistant TB, but sensitive to levofloxacin and moxifloxacin

Exclusion Criteria:

* 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

Primary outcomes:
measure: Negative conversion of M. tuberculosis
timeFrame: 3 months after initiation of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungbuk
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi
city: Bucheon
country: Korea, Republic of
facility: Catholic University of Korea Bucheon St. Mary's Hospital
state: Gyeonggi
city: Bundang
country: Korea, Republic of
facility: Bundang CHA Hospital
state: Gyeonggi
city: Bundang
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
city: Pyeongchon
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Masan
country: Korea, Republic of
facility: Masan Samsung Medical Center
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Yong-san Hospital
city: Seoul
country: Korea, Republic of
facility: East-West Neo Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Korean Institute of Tuberculosis
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jae-Joon Yim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.