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Comparison of the Effect Between Levofloxacin and Moxifloxacin Among MDR-TB Patients

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: TB

Intervention: levofloxacin, moxifloxacin (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Jae-Joon Yim, MD, Principal Investigator, Affiliation: Seoul National University Hospital

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Negative conversion of M. tuberculosis

Eligibility

Minimum age: 20 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Kangwon National University Hospital, Chuncheon, Korea, Republic of

Daegu Catholic University Medical Center, Daegu, Korea, Republic of

Keimyung University Dongsan Medical Center, Daegu, Korea, Republic of

Chonnam National University Hospital, Gwangju, Korea, Republic of

Gachon University Gil Hospital, Incheon, Korea, Republic of

Gyeongsang National University Hospital, Jinju, Korea, Republic of

Masan Samsung Medical Center, Masan, Korea, Republic of

Inje University Pusan Paik Hospital, Pusan, Korea, Republic of

Pusan National University Hospital, Pusan, Korea, Republic of

Asan Medical Center, Seoul, Korea, Republic of

Chung-Ang University Yong-san Hospital, Seoul, Korea, Republic of

East-West Neo 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 Anam Hospital, Seoul, Korea, Republic of

Korea University Guro Hospital, Seoul, Korea, Republic of

Korean Institute of Tuberculosis, Seoul, Korea, Republic of

Samsung Medical Center, Seoul, Korea, Republic of

Seoul Medical Center, Seoul, Korea, Republic of

Seoul National University Boramae Medical Center, Seoul, Korea, Republic of

Seoul National University Hospital, Seoul 110-744, Korea, Republic of

Severance Hospital, Seoul, Korea, Republic of

Chungbuk National University Hospital, Cheongju, Chungbuk, Korea, Republic of

Korea University Ansan Hospital, Ansan, Gyeonggi, Korea, Republic of

Catholic University of Korea Bucheon St. Mary's Hospital, Bucheon, Gyeonggi, Korea, Republic of

Bundang CHA Hospital, Bundang, Gyeonggi, Korea, Republic of

Seoul National University Bundang Hospital, Bundang, Gyeonggi, Korea, Republic of

Hallym University Sacred Heart Hospital, Pyeongchon, Gyeonggi, Korea, Republic of

Additional Information

Starting date: March 2010
Last updated: November 22, 2012

Page last updated: August 23, 2015

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