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Treatment Shortening of MDR-TB Using Existing and New Drugs (MDR-END)

This study is currently recruiting participants.
Verified May 2016 by Jae-Joon Yim, Seoul National University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02619994
First Posted: December 2, 2015
Last Update Posted: May 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Asan Medical Center
Dankook University
International Tuberculosis Research Center
Pusan National University Yangsan Hospital
Pusan National University Hospital
Samsung Medical Center
Severance Hospital
SMG-SNU Boramae Medical Center
Incheon St.Mary's Hospital
Ulsan University Hospital
Korean Institute of Tuberculosis
National Medical Center, Seoul
Korean Center for Disease Control and Prevention
Information provided by (Responsible Party):
Jae-Joon Yim, Seoul National University Hospital
  Purpose
The purpose of this study is to compare the efficacy of a 'new treatment regimen including delamanid, linezolid, levofloxacin, and pyrazinamide for nine or twelve months (investigational arm)' and 'the standard treatment regimen including injectables for 20 to 24 months (control arm)' for treating quinolone sensitive multidrug-resistant tuberculosis.

Condition Intervention Phase
Tuberculosis, Multidrug-Resistant Drug: Linezolid Drug: Delamanid Drug: Levofloxacin Drug: Pyrazinamide Drug: Locally-used WHO-approved MDR-TB regimen in Korea Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Delamanid, Linezolid, Levofloxacin, and Pyrazinamide for Treatment of Patients With Fluoroquinolone-sensitive MDR-TB: A Phase 2, Multicenter, Randomized, Open-label, Clinical Trial

Resource links provided by NLM:


Further study details as provided by Jae-Joon Yim, Seoul National University Hospital:

Primary Outcome Measures:
  • Treatment success rate [ Time Frame: 24 months after treatment start ]

Secondary Outcome Measures:
  • Time to sputum culture conversion to negative (liquid and solid culture medium) [ Time Frame: During 6 months of treatment ]
    From date of randomization until the date of conversion assessed up to 6 months

  • Sputum culture conversion proportion (liquid culture medium) [ Time Frame: At 2 months of treatment ]
  • Sputum culture conversion proportion (liquid culture medium) [ Time Frame: At six months of treatment ]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Through study completion, an average of 2 years ]

Estimated Enrollment: 238
Study Start Date: January 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Arm

Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.

  • Intensive phase regimen consists of four effective second-line anti-TB drugs (including injectables) and pyrazinamide.
  • Treatment duration: for at least 20 months
Drug: Locally-used WHO-approved MDR-TB regimen in Korea
Experimental: Experimental Arm

Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.

  • Delamanid (100 mg bid for the entire treatment period)
  • Linezolid (600mg/day for 2 months and 300mg/day afterwards until the end of treatment)
  • Levofloxacin (750 ~1000 mg/day)
  • Pyrazinamide (1000~ 2000 mg/day)
Drug: Linezolid Drug: Delamanid Drug: Levofloxacin Drug: Pyrazinamide

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females aged from 19 to 85 years
  • Confirmed Rifampicin resistance
  • On current TB therapy for ≤14 days at the time of enrollment.

Exclusion Criteria:

  • Known any quinolone-resistant MDR-TB patients
  • Known XDR-TB patients
  • Patients who are pregnant or who are unwilling to use proper contraceptives at childbearing age
  • Medical history of galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • The need for ongoing use of prohibited drugs while on study drugs
  • History of optic neuropathy or peripheral neuropathy
  • People with any of the following test results: i.Absolute neutrophil count < 2000 cells/mL, ii.White blood cell count (WBC) < 3.0 X 103/µL, iii.Hemoglobin < 7.0 g/dL, iv.Serum creatinine > 2.0 mg/dL, v.Aspartate aminotransferase (AST or SGOT) >100 IU/L, vi.Alanine aminotransferase (ALT or SGPT) >100 IU/L, vii.Total bilirubin > 2.0 mg/dL, viii.Albumin < 2.8g/dL, ix.QTcF > 500ms
  • History of hypersensitivity reaction to the study drugs
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619994


Contacts
Contact: Jae-Joon Yim, MD +82-2-2072-2059 yimjj@snu.ac.kr

Locations
Korea, Republic of
Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jae-Joon Yim, MD    +82-2-2072-2059    yimjj@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Asan Medical Center
Dankook University
International Tuberculosis Research Center
Pusan National University Yangsan Hospital
Pusan National University Hospital
Samsung Medical Center
Severance Hospital
SMG-SNU Boramae Medical Center
Incheon St.Mary's Hospital
Ulsan University Hospital
Korean Institute of Tuberculosis
National Medical Center, Seoul
Korean Center for Disease Control and Prevention
  More Information

Responsible Party: Jae-Joon Yim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02619994     History of Changes
Other Study ID Numbers: MDR-END
First Submitted: November 24, 2015
First Posted: December 2, 2015
Last Update Posted: May 3, 2016
Last Verified: May 2016

Keywords provided by Jae-Joon Yim, Seoul National University Hospital:
MDR tuberculosis
linezolid
delamanid
Korea

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Multidrug-Resistant
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Levofloxacin
Ofloxacin
Linezolid
Pyrazinamide
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Protein Synthesis Inhibitors
Antitubercular Agents