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

TB Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01055145
• Other study ID #: H-0911-068-301
• Status: Terminated
• Phase: Phase 3
• First received: January 21, 2010
• Last updated: November 22, 2012
• Start date: March 2010
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 182
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• TB

Intervention

Drug:
• levofloxacin, moxifloxacin
Levofloxacin 750mg po per day for 3 months vs. Moxifloxacin 400mg po per day for 3 months

Locations

Country	Name	City	State
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	Chungbuk National University Hospital	Cheongju	Chungbuk
Korea, Republic of	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	Hallym University Sacred Heart Hospital	Pyeongchon	Gyeonggi
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
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative conversion of M. tuberculosis		3 months after initiation of treatment	No