- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01994460
Linezolid Instead of Ethambutol in Treatment of Drug-susceptible Tuberculosis
Substitution of Ethambutol With Linezolid During the Intensive Phase of Treatment of Pulmonary Tuberculosis: A Prospective, Multicenter, Randomized, Open-label Phase II Trial
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Jae-Joon Yim, MD
- Phone Number: 82-2-2072-2059
- Email: yimjj@snu.ac.kr
Study Locations
-
-
-
Seoul, Korea, Republic of, 156-707
- Recruiting
- SMG-SNU Boramae Medical Center
-
Contact:
- Deog Kyeom Kim, MD
- Phone Number: 02-870-2228
- Email: kimdkmd@gmail.com
-
Principal Investigator:
- Deog Kyeom Kim, MD
-
Seoul, Korea, Republic of, 100-799
- Recruiting
- National Medical Center
-
Contact:
- Ji Yeon Lee, MD
- Phone Number: 82222607284
- Email: jedidiah125@gmail.com
-
Principal Investigator:
- Ji Yeon Lee, MD
-
-
Kyunggi
-
Seongnam, Kyunggi, Korea, Republic of, 463-707
- Recruiting
- Seoul National University Bundang Hospital
-
Contact:
- Jong Sun Park, MD
- Phone Number: 031-787-7054
- Email: jspark.im@gmail.com
-
Principal Investigator:
- Jong Sun Park, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males and females aged from 20 to 80 years (20- and 80-year-old patients can participate).
- Documented sputum Xpert MTB/RIF assay-positive pulmonary TB at screening.
- On current TB therapy (if any) for ≤14 days at the time of enrollment.
Exclusion Criteria:
- Patients with HIV/AIDS.
- Females of childbearing potential, who are pregnant, breastfeeding, or unwilling to avoid pregnancy.
Any of the following:
i.Absolute neutrophil count of <2000 cells/mL. ii.White blood cell count (WBC) of <3000/μL. iii.Hemoglobin concentration of <7.0 g/dL. iv.Serum creatinine level of >2.0 mg/dL. v.Aspartate aminotransferase (AST or SGOT) of >100 IU/L. vi.Alanine aminotransferase (ALT or SGPT) of >100 IU/L. vii.Total bilirubin level of >2.0 mg/dL. viii.History of optic neuritis or peripheral neuropathy. ix.Other significant laboratory abnormalities (i.e., absolute neutrophil count, creatinine level).
x.The need for ongoing therapy with SSRIs, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine, buspirone, monoamine oxidase inhibitors (MAOIs), sympathomimetic agents (e.g., pseudoephedrine), vasopressive agents (e.g., epinephrine, norepinephrine), or dopaminergic agents (e.g., dopamine, dobutamine).
Study Plan
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: Arm 1 (control arm)
Standard treatment for drug-sensitive pulmonary TB using isoniazid (6 months), rifampicin (6 months), pyrazinamide (2 months), and ethambutol (2 months)
|
|
Experimental: Arm 2 (experimental arm 1)
Isoniazid (6 months), rifampicin (6 months), pyrazinamide (2 months), and linezolid (600 mg/day, 2 weeks)
|
|
Experimental: Arm 3 (experimental arm 2)
Isoniazid (6 months), rifampicin (6 months), pyrazinamide (2 months), and linezolid (600 mg/day, 4 weeks)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sputum culture conversion rate on liquid media
Time Frame: after 2 months of treatment
|
after 2 months of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sputum culture conversion rate on solid media
Time Frame: after 2 months of treatment
|
after 2 months of treatment
|
Time to sputum culture conversion (liquid and solid media)
Time Frame: During 6 months of treatment
|
During 6 months of treatment
|
Cure rate
Time Frame: After 6 months of treatment
|
After 6 months of treatment
|
Treatment success rate
Time Frame: after 6 months of treatment
|
after 6 months of treatment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jae-Joon Yim, MD, Seoul National University Hospital
Publications and helpful links
General Publications
- Lee JK, Lee JY, Kim DK, Yoon HI, Jeong I, Heo EY, Park YS, Jo YS, Lee JH, Park SS, Park JS, Kim J, Lee SM, Joh JS, Lee CH, Lee J, Choi SM, Park JH, Lee SH, Cho YJ, Lee YJ, Kim SJ, Kwak N, Hwang YR, Kim H, Ki J, Lim JN, Choi HS, Lee M, Song T, Kim HS, Han J, Ahn H, Hahn S, Yim JJ. Substitution of ethambutol with linezolid during the intensive phase of treatment of pulmonary tuberculosis: a prospective, multicentre, randomised, open-label, phase 2 trial. Lancet Infect Dis. 2019 Jan;19(1):46-55. doi: 10.1016/S1473-3099(18)30480-8. Epub 2018 Nov 23.
- Lee JY, Kim DK, Lee JK, Yoon HI, Jeong I, Heo E, Park YS, Lee JH, Park SS, Lee SM, Lee CH, Lee J, Choi SM, Park JS, Joh JS, Cho YJ, Lee YJ, Kim SJ, Hwang YR, Kim H, Ki J, Choi H, Han J, Ahn H, Hahn S, Yim JJ. Substitution of ethambutol with linezolid during the intensive phase of treatment of pulmonary tuberculosis: study protocol for a prospective, multicenter, randomized, open-label, phase II trial. Trials. 2017 Feb 13;18(1):68. doi: 10.1186/s13063-017-1811-0.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Tuberculosis
- Tuberculosis, Pulmonary
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Antitubercular Agents
- Linezolid
- Ethambutol
Other Study ID Numbers
- J-1310-026-523
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.
Clinical Trials on Pulmonary Tuberculosis Without Resistance to Rifampicin
-
Foundation for Innovative New Diagnostics, SwitzerlandInstitute of Tropical Medicine, Belgium; Research Center Borstel; National Institute...CompletedMultidrug-Resistant Tuberculosis | Isoniazid Resistant Pulmonary Tuberculosis | Rifampicin Resistant Tuberculosis | Pulmonary Tuberculoses
-
Thirty Respiratory LimitedRecruitingRifampicin Susceptible Pulmonary TuberculosisSouth Africa
-
Universiteit AntwerpenAurum Institute; University of Stellenbosch; University of the Free State; Free...RecruitingDrug-resistant Tuberculosis | Rifampicin Resistant Tuberculosis | Pulmonary Tuberculoses | Multidrug Resistant TuberculosisSouth Africa
-
TASK Applied ScienceRecruitingRifampicin- and Isoniazid-Susceptible Pulmonary Tuberculosis (TB)South Africa
-
Beijing Chest HospitalNational Medical Center for Infectious DiseasesRecruitingPulmonary Tuberculosis | Rifampicin-resistant TuberculosisChina
-
Institute of Tropical Medicine, BelgiumDamien FoundationActive, not recruitingTuberculosis | Pulmonary Tuberculosis | Multidrug-resistant Tuberculosis | Resistance to Tuberculostatic DrugsNiger
-
University of California, San FranciscoLondon School of Hygiene and Tropical Medicine; National Heart, Lung, and Blood... and other collaboratorsCompletedTuberculosis, Pulmonary | Rifampicin Resistant TuberculosisUganda
-
Desmond Tutu HIV FoundationNational Institutes of Health (NIH); University of Cape Town; Zeteo Tech IncorporatedCompletedPulmonary Tuberculosis Confirmation by Sputum Microscopy With or Without CultureSouth Africa
-
Hasanuddin UniversityChulalongkorn UniversityCompletedResistance to Tuberculostatic Drugs | MDR TuberculosisIndonesia
-
National Taiwan University HospitalUnknownTo Compare the Serum Apoptosis-associated Markers Between Patients With Active TB and Patients With LTBI | To Evaluate the Efficiency of Apoptosis-associated Markers to Differentiate Potential of Active TB From LTBITaiwan
Clinical Trials on Linezolid
-
PfizerCompletedVancomycin Resistance Enterococcus Faecium
-
Mabwell (Shanghai) Bioscience Co., Ltd.Recruiting
-
National Institute of Allergy and Infectious Diseases...CompletedPulmonary Tuberculosis | Multidrug Resistant Tuberculosis | Extensively Drug Resistant TuberculosisKorea, Republic of
-
October 6 UniversityBeni-Suef UniversityRecruiting
-
PfizerCompletedMethicillin Resistant Staphylococcus Aureus (MRSA)United States, Greece, Colombia, Korea, Republic of, Russian Federation, Turkey, Brazil, Chile, Taiwan, Mexico, Belgium, Spain, Hong Kong, Puerto Rico, France, United Kingdom, Malaysia, Germany, South Africa, Portugal, Argentina, ...
-
Furiex Pharmaceuticals, IncCompletedComplicated Skin and Skin Structure InfectionsUnited States
-
PfizerCompleted
-
WockhardtCompletedAcute Bacterial Skin and Skin Structure InfectionsIndia
-
PfizerCompletedInfections, NosocomialJapan
-
PfizerCompletedGram-Positive Bacterial Infections | Skin and Connective Tissue Diseases