Treatment Shortening of MDR-TB Using Existing and New Drugs

• Status: Unknown status
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Asan Medical Center; Dankook University; Incheon St.Mary's Hospital; International Tuberculosis Research Center; Korea University; Korean Center for Disease Control and Prevention; Korean Institute of Tuberculosis; National Medical Center, Seoul; Pusan National University Hospital; Pusan National University Yangsan Hospital; Samsung Medical Center; Severance Hospital; SMG-SNU Boramae Medical Center; Ulsan University Hospital
• Treatments: Levofloxacin; Linezolid; Ofloxacin; Pyrazinamide

Criteria

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/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