TBPhase 3NCT01055145
Comparison of the Effect Between Levofloxacin and Moxifloxacin Among MDR-TB Patients
A Phase 3 study testing levofloxacin, moxifloxacin in people with TB, run by Seoul National University Hospital at 29 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- TB
- What is being tested?
- levofloxacin, moxifloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 29 sitesSouth Korea
- Study dates
- Mar 2010to Oct 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with multidrug-resistant TB, but sensitive to levofloxacin and moxifloxacin
Who cannot join
- 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
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
South Korea29 sites
Korea University Ansan Hospital
Ansan, Gyeonggi-do
Catholic University of Korea Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do
Bundang CHA Hospital
Bundang, Gyeonggi-do
Seoul National University Bundang Hospital
Bundang, Gyeonggi-do
Chungbuk National University Hospital
Cheongju-si, North Chungcheong
Kangwon National University Hospital
Chuncheon
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Medical Center
Daegu
Chonnam National University Hospital
Gwangju
Gachon University Gil Hospital
Incheon
Gyeongsang National University Hospital
Jinju
Masan Samsung Medical Center
Masan
Inje University Pusan Paik Hospital
Pusan
Pusan National University Hospital
Pusan
Hallym University Sacred Heart Hospital
Pyeongchon, Gyeonggi-do
Seoul National University Hospital
Seoul, Seoul, 110-744
Asan Medical Center
Seoul
Chung-Ang University Yong-san Hospital
Seoul
East-West Neo Medical Center
Seoul
Ewha Womans University Mokdong Hospital
Seoul
Inje University Sanggye Paik Hospital
Seoul
Kangbuk Samsung Medical Center
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Korean Institute of Tuberculosis
Seoul
Samsung Medical Center
Seoul
Seoul Medical Center
Seoul
Seoul National University Boramae Medical Center
Seoul
Severance Hospital
Seoul
About this study
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
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.
- Conditions
- TB
- Being tested
- levofloxacin, moxifloxacin
- Keywords
- Multidrug-resistant TB, sensitive to levofloxacin and moxifloxacin
- Medical subject headings
- Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levofloxacin, moxifloxacinDrug
Levofloxacin 750mg po per day for 3 months vs. Moxifloxacin 400mg po per day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| levofloxacin | Active comparator | Levofloxacin 750mg po per day for 3 months Receives: Drug: levofloxacin, moxifloxacin |
| moxifloxacin | Active comparator | Moxifloxacin 400mg po per day for 3 months Receives: Drug: levofloxacin, moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative conversion of M. tuberculosis
Measured: 3 months after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TBStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jae-Joon Yim, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055145
- Sponsor's protocol ID
- H-0911-068-301
- Status last verified
- Nov 2012
- First submitted
- 21 Jan 2010
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kang YA, Shim TS, Koh WJ, Lee SH, Lee CH, Choi JC, Lee JH, Jang SH, Yoo KH, Jung KH, Kim KU, Choi SB, Ryu YJ, Kim KC, Um S, Kwon YS, Kim YH, Choi WI, Jeon K, Hwang YI, Kim SJ, Lee HK, Heo E, Yim JJ. Choice between Levofloxacin and Moxifloxacin and Multidrug-Resistant Tuberculosis Treatment Outcomes. Ann Am Thorac Soc. 2016 Mar;13(3):364-70. doi: 10.1513/AnnalsATS.201510-690BC.
PubMed 26871879Koh WJ, Lee SH, Kang YA, Lee CH, Choi JC, Lee JH, Jang SH, Yoo KH, Jung KH, Kim KU, Choi SB, Ryu YJ, Chan Kim K, Um S, Kwon YS, Kim YH, Choi WI, Jeon K, Hwang YI, Kim SJ, Lee YS, Heo EY, Lee J, Ki YW, Shim TS, Yim JJ. Comparison of levofloxacin versus moxifloxacin for multidrug-resistant tuberculosis. Am J Respir Crit Care Med. 2013 Oct 1;188(7):858-64. doi: 10.1164/rccm.201303-0604OC.
PubMed 23927582
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01055145
- Acronym / sponsor ID
- H-0911-068-301
- Conditions
- TB
- Keywords
- Multidrug-resistant TB, sensitive to levofloxacin and moxifloxacin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 25 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| levofloxacin | Active comparator | Drug: levofloxacin, moxifloxacinLevofloxacin 750mg po per day for 3 months |
| moxifloxacin | Active comparator | Drug: levofloxacin, moxifloxacinMoxifloxacin 400mg po per day for 3 months |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with multidrug-resistant TB, but sensitive to levofloxacin and moxifloxacin
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levofloxacin, moxifloxacinLevofloxacin 750mg po per day for 3 months vs. Moxifloxacin 400mg po per day for 3 months | Drug | levofloxacin, moxifloxacin |
Primary outcome
Negative conversion of M. tuberculosis
Time frame: 3 months after initiation of treatment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
- Derived from this study: PubMed 26871879Kang YA, Shim TS, Koh WJ, Lee SH, Lee CH, Choi JC, Lee JH, Jang SH, Yoo KH, Jung KH, Kim KU, Choi SB, Ryu YJ, Kim KC, Um S, Kwon YS, Kim YH, Choi WI, Jeon K, Hwang YI, Kim SJ, Lee HK, Heo E, Yim JJ. Choice between Levofloxacin and Moxifloxacin and Multidrug-Resistant Tuberculosis Treatment Outcomes. Ann Am Thorac Soc. 2016 Mar;13(3):364-70. doi: 10.1513/AnnalsATS.201510-690BC.
- Derived from this study: PubMed 23927582Koh WJ, Lee SH, Kang YA, Lee CH, Choi JC, Lee JH, Jang SH, Yoo KH, Jung KH, Kim KU, Choi SB, Ryu YJ, Chan Kim K, Um S, Kwon YS, Kim YH, Choi WI, Jeon K, Hwang YI, Kim SJ, Lee YS, Heo EY, Lee J, Ki YW, Shim TS, Yim JJ. Comparison of levofloxacin versus moxifloxacin for multidrug-resistant tuberculosis. Am J Respir Crit Care Med. 2013 Oct 1;188(7):858-64. doi: 10.1164/rccm.201303-0604OC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae-Joon Yim, MD principal investigator
Seoul National University Hospital
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing levofloxacin, moxifloxacin in people with TB, run by Seoul National University Hospital at 29 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative conversion of M. tuberculosis (time frame: 3 months after initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01055145, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.