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

Purpose

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.

Condition	Intervention	Phase
TB	Drug: levofloxacin, moxifloxacin	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

Negative conversion of M. tuberculosis [ Time Frame: 3 months after initiation of treatment ] [ Designated as safety issue: No ]

Enrollment:	182
Study Start Date:	March 2010
Study Completion Date:	October 2012
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: levofloxacin Levofloxacin 750mg po per day for 3 months	Drug: levofloxacin, moxifloxacin Levofloxacin 750mg po per day for 3 months vs. Moxifloxacin 400mg po per day for 3 months
Active Comparator: moxifloxacin Moxifloxacin 400mg po per day for 3 months	Drug: levofloxacin, moxifloxacin Levofloxacin 750mg po per day for 3 months vs. Moxifloxacin 400mg po per day for 3 months

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055145

Locations

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
Seoul National University Bundang Hospital
Bundang, Gyeonggi, Korea, Republic of
Bundang CHA Hospital
Bundang, Gyeonggi, Korea, Republic of
Hallym University Sacred Heart Hospital
Pyeongchon, Gyeonggi, 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
Pusan National University Hospital
Pusan, Korea, Republic of
Inje University Pusan Paik Hospital
Pusan, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Seoul Medical Center
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of
East-West Neo Medical Center
Seoul, Korea, Republic of
Chung-Ang University Yong-san Hospital
Seoul, Korea, Republic of
Kangbuk Samsung Medical Center
Seoul, Korea, Republic of
Inje University Sanggye Paik Hospital
Seoul, Korea, Republic of
Seoul National University Boramae Medical Center
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Korean Institute of Tuberculosis
Seoul, Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator:

Jae-Joon Yim, MD

Seoul National University Hospital

More Information

No publications provided

Responsible Party:	Jae-Joon Yim / Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT01055145 History of Changes
Other Study ID Numbers:	H-0911-068-301
Study First Received:	January 21, 2010
Last Updated:	November 22, 2012
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

Multidrug-resistant TB, sensitive to levofloxacin and moxifloxacin

Additional relevant MeSH terms:

Ofloxacin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013