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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01055145

Enrollment

182

Registered

2010-01-25

Start date

2010-03-31

Completion date

2012-10-31

Last updated

2012-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keywords

Multidrug-resistant TB, sensitive to levofloxacin and moxifloxacin

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.

Interventions

DRUGlevofloxacin, moxifloxacin

Levofloxacin 750mg po per day for 3 months vs. Moxifloxacin 400mg po per day for 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Negative conversion of M. tuberculosis	3 months after initiation of treatment

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026