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

November 22, 2012 updated by: Seoul National University Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Chuncheon, Korea, Republic of
        • Kangwon National University Hospital
      • Daegu, Korea, Republic of
        • Daegu Catholic University Medical Center
      • Daegu, Korea, Republic of
        • Keimyung University Dongsan Medical Center
      • Gwangju, Korea, Republic of
        • Chonnam National University Hospital
      • Incheon, Korea, Republic of
        • Gachon University Gil Hospital
      • Jinju, Korea, Republic of
        • Gyeongsang National University Hospital
      • Masan, Korea, Republic of
        • Masan Samsung Medical Center
      • Pusan, Korea, Republic of
        • Pusan National University Hospital
      • Pusan, Korea, Republic of
        • Inje University Pusan Paik Hospital
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Kangbuk Samsung Medical Center
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • Seoul Medical Center
      • Seoul, Korea, Republic of
        • Seoul National University Boramae Medical Center
      • Seoul, Korea, Republic of
        • Inje University Sanggye Paik Hospital
      • Seoul, Korea, Republic of
        • East-west neo medical center
      • Seoul, Korea, Republic of
        • Korean Institute of Tuberculosis
      • Seoul, Korea, Republic of
        • Chung-Ang University Yong-san Hospital
    • Chungbuk
      • Cheongju, Chungbuk, Korea, Republic of
        • Chungbuk National University Hospital
    • Gyeonggi
      • Ansan, Gyeonggi, Korea, Republic of
        • Korea University Ansan Hospital
      • Bucheon, Gyeonggi, Korea, Republic of
        • Catholic University of Korea Bucheon St. Mary's Hospital
      • Bundang, Gyeonggi, Korea, Republic of
        • Bundang CHA Hospital
      • Bundang, Gyeonggi, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Pyeongchon, Gyeonggi, Korea, Republic of
        • Hallym University Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Negative conversion of M. tuberculosis
Time Frame: 3 months after initiation of treatment
3 months after initiation of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jae-Joon Yim, MD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

January 21, 2010

First Submitted That Met QC Criteria

January 22, 2010

First Posted (Estimate)

January 25, 2010

Study Record Updates

Last Update Posted (Estimate)

November 27, 2012

Last Update Submitted That Met QC Criteria

November 22, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-0911-068-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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