Treatment Shortening of MDR-TB Using Existing and New Drugs

  • STATUS
    Recruiting
  • day left to enroll
    1
  • participants needed
    238
  • sponsor
    Seoul National University Hospital
Updated on 22 January 2021
fluoroquinolones
linezolid
pyrazinamide
treatment regimen
levofloxacin
delamanid

Summary

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 fluoroquinolone-sensitive multidrug-resistant tuberculosis.

Description

This study is a phase II/III, multicenter, randomized, open-label clinical trial of non-inferiority design comparing a new regimen to the World Health Organization-endorsed conventional regimen for fluoroquinolone-sensitive MDR-TB. The control arm uses a conventional treatment regimen with second-line drugs including injectables for 20-24 months. The investigational arm uses a new shorter regimen including delamanid, linezolid, levofloxacin, and pyrazinamide for 9 or 12 months depending on time to sputum culture conversion. The primary outcome is the treatment success rate at 24 months after treatment initiation. Secondary outcomes include time to sputum culture conversion on liquid and solid media, proportions of sputum culture conversion on liquid media after 2 and 6 months of treatment, treatment success rate according to pyrazinamide resistance, and occurrence of adverse events grade 3 and above as evaluated by the Common Terminology Criteria for Adverse Events. The population number is calculated as 102 per group (204 in total).

Details
Condition drug-resistant tuberculosis
Treatment pyrazinamide, levofloxacin, delamanid, linezolid, Locally-used WHO-approved MDR-TB regimen in Korea
Clinical Study IdentifierNCT02619994
SponsorSeoul National University Hospital
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Males and females aged from 19 to 85 years
Confirmed MDR-TB or RR-TB
On current TB therapy for 14 days at the time of enrollment

Exclusion Criteria

Known any quinolone-resistant MDR-TB
Known XDR-TB
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
With any of the following test results: i.Absolute neutrophil count < 2000 cells/mL, ii.White blood cell count (WBC) < 3.0 X 103/L, 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
Clear my responses

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