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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01994460

Enrollment

429

Registered

2013-11-25

Start date

2014-01-31

Completion date

2016-06-30

Last updated

2014-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Tuberculosis Without Resistance to Rifampicin

Keywords

Tuberculosis

Brief summary

The current standard short-course treatment for pulmonary TB requires 6 months to complete. This long duration of treatment increases the likelihood of side effects while decreasing patients' adherence to anti-TB drugs. Linezolid showed considerable efficacy against refractory multidrug-resistant TB. Considering the marked anti-TB effects of linezolid as well as the possible adverse effects of its long-term use, it is rational to use linezolid instead of ethambutol for the first 4 weeks of treatment for drug-susceptible pulmonary TB. Through randomized controlled trial, the investigators will evaluate the hypothesis that the use of linezolid instead of ethambutol will increase the sputum culture conversion rate by 15% after 2 months of treatment. Patients with TB without resistance to rifampicin will be randomized to the following three arms at a 1:1:1 ratio: Arma 1 (control arm), Arm 2 (linezolid for 2 weeks instead of ethambutol), Arm 3 (linezolid for 4 weeks instead of ethambutol)Primary outcome will be sputum culture conversion rate after 2 months of treatment (liquid media).

Interventions

DRUGLinezolid

DRUGEthambutol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
Sputum culture conversion rate on liquid media	after 2 months of treatment

Secondary

Measure	Time frame
Sputum culture conversion rate on solid media	after 2 months of treatment
Time to sputum culture conversion (liquid and solid media)	During 6 months of treatment
Cure rate	After 6 months of treatment
Treatment success rate	after 6 months of treatment

Countries

South Korea

Contacts

Primary ContactJae-Joon Yim, MD

yimjj@snu.ac.kr82-2-2072-2059

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026