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Linezolid to Treat Extensively-Drug Resistant Tuberculosis

NCT00727844 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2016-03-14

Study results available
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Summary

This study, conducted in Masan and Seoul, South Korea, investigated the effectiveness of linezolid (LZD) in treating patients with extensively drug resistant tuberculosis (XDR TB). Because regular medicines do not work well against XDR TB, many more people die from it than from regular TB, which can be successfully treated by taking TB medication for 6 months. Linezolid has been used to treat other kinds of infections, but has not been well studied for TB. This study examined the side effects and effectiveness of prolonged treatment with linezolid at two different doses.

People 20 years of age and older who have XDR TB were eligible for this 3-year study.

Participants underwent the following tests and procedures:

* LZD treatment: Patients were randomly assigned to one of two study groups. Group 1 patients were observed for 2 months before starting LZD, while group 2 patients begin taking LZD right away. Both groups began with a 600 mg daily dose of LZD. After patients stopped coughing up TB germs (or after 4 months on LZD) they were randomly assigned either to continue taking 600 mg of LZD for the rest of the study or to take a decreased dose of 300 mg. In addition to LZD, patients continued to take their currently prescribed TB medications.
* Medical history.
* Physical examinations each month during treatment.
* Sputum collections once a week or more until 3 weeks after the patient was no longer contagious.
* Blood draws every week for 16 to 24 weeks and then once a month.
* Urine collections at several time points.
* Nerve and eye examinations before starting treatment and then monthly to look for possible LZD side effects.
* CT scans of the lungs three to four times the first year and once more later in the study. For this test the patient lay on a table within the doughnut-shaped CT scanner while special X-ray pictures are taken.

Patients who participated in a substudy had PET scans instead of the CT scans. For this test, the patient was given an injection into a vein of a radioactive chemical that can be detected by a special camera and viewed on a screen. The patient lay on a table within the doughnut-shaped scanner while pictures were taken.

Conditions

  • Pulmonary Tuberculosis
  • Multidrug Resistant Tuberculosis
  • Extensively Drug Resistant Tuberculosis

Interventions

DRUG

Immediate Start Linezolid

DRUG

Delayed Start Linezolid

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Clifton Barry, Ph.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2012-10-31
Completion
2014-11-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00727844 on ClinicalTrials.gov