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Linezolid Instead of Ethambutol in Treatment of Drug-susceptible Tuberculosis

NCT ID: NCT01994460

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

429 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Pulmonary Tuberculosis Without Resistance to Rifampicin

Keywords

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Tuberculosis

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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Arm 1 (control arm)

Standard treatment for drug-sensitive pulmonary TB using isoniazid (6 months), rifampicin (6 months), pyrazinamide (2 months), and ethambutol (2 months)

Group Type ACTIVE_COMPARATOR

Ethambutol

Intervention Type DRUG

Arm 2 (experimental arm 1)

Isoniazid (6 months), rifampicin (6 months), pyrazinamide (2 months), and linezolid (600 mg/day, 2 weeks)

Group Type EXPERIMENTAL

Linezolid

Intervention Type DRUG

Arm 3 (experimental arm 2)

Isoniazid (6 months), rifampicin (6 months), pyrazinamide (2 months), and linezolid (600 mg/day, 4 weeks)

Group Type EXPERIMENTAL

Linezolid

Intervention Type DRUG

Interventions

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Linezolid

Intervention Type DRUG

Ethambutol

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health & Welfare, Korea

OTHER_GOV

Sponsor Role collaborator

SMG-SNU Boramae Medical Center

OTHER

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae-Joon Yim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae-Joon Yim, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, Kyunggi, South Korea

Site Status RECRUITING

National Medical Center

Seoul, Seoul, South Korea

Site Status RECRUITING

SMG-SNU Boramae Medical Center

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jae-Joon Yim, MD

Role: CONTACT

Phone: 82-2-2072-2059

Email: [email protected]

Facility Contacts

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Jong Sun Park, MD

Role: primary

Ji Yeon Lee, MD

Role: primary

Deog Kyeom Kim, MD

Role: primary

References

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Lee JK, Lee JY, Kim DK, Yoon HI, Jeong I, Heo EY, Park YS, Jo YS, Lee JH, Park SS, Park JS, Kim J, Lee SM, Joh JS, Lee CH, Lee J, Choi SM, Park JH, Lee SH, Cho YJ, Lee YJ, Kim SJ, Kwak N, Hwang YR, Kim H, Ki J, Lim JN, Choi HS, Lee M, Song T, Kim HS, Han J, Ahn H, Hahn S, Yim JJ. Substitution of ethambutol with linezolid during the intensive phase of treatment of pulmonary tuberculosis: a prospective, multicentre, randomised, open-label, phase 2 trial. Lancet Infect Dis. 2019 Jan;19(1):46-55. doi: 10.1016/S1473-3099(18)30480-8. Epub 2018 Nov 23.

Reference Type DERIVED
PMID: 30477961 (View on PubMed)

Lee JY, Kim DK, Lee JK, Yoon HI, Jeong I, Heo E, Park YS, Lee JH, Park SS, Lee SM, Lee CH, Lee J, Choi SM, Park JS, Joh JS, Cho YJ, Lee YJ, Kim SJ, Hwang YR, Kim H, Ki J, Choi H, Han J, Ahn H, Hahn S, Yim JJ. Substitution of ethambutol with linezolid during the intensive phase of treatment of pulmonary tuberculosis: study protocol for a prospective, multicenter, randomized, open-label, phase II trial. Trials. 2017 Feb 13;18(1):68. doi: 10.1186/s13063-017-1811-0.

Reference Type DERIVED
PMID: 28193240 (View on PubMed)

Other Identifiers

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J-1310-026-523

Identifier Type: -

Identifier Source: org_study_id