Treatment Shortening of MDR-TB Using Existing and New Drugs

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Tuberculosis, Multidrug-Resistant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Locally-used WHO-approved MDR-TB regimen in Korea

Intervention Type DRUG

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)

Group Type EXPERIMENTAL

Linezolid

Intervention Type DRUG

Delamanid

Intervention Type DRUG

Levofloxacin

Intervention Type DRUG

Pyrazinamide

Intervention Type DRUG

Interventions

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Linezolid

Intervention Type DRUG

Delamanid

Intervention Type DRUG

Levofloxacin

Intervention Type DRUG

Pyrazinamide

Intervention Type DRUG

Locally-used WHO-approved MDR-TB regimen in Korea

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No