Linezolid to Treat Extensively-Drug Resistant Tuberculosis
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ClinicalTrials.gov Identifier: NCT00727844 |
Recruitment Status :
Completed
First Posted : August 4, 2008
Results First Posted : February 24, 2014
Last Update Posted : March 14, 2016
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Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Clifton E. Barry III, Ph.D., National Institute of Allergy and Infectious Diseases (NIAID)
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Pulmonary Tuberculosis Multidrug Resistant Tuberculosis Extensively Drug Resistant Tuberculosis |
Interventions |
Drug: Immediate Start Linezolid Drug: Delayed Start Linezolid |
Enrollment | 41 |
Participant Flow
Recruitment Details | Study patients recruited from 12/2008 to 5/2011 at the National Masan Hospital, Changwon, Korea and the National Medical Center, Seoul, Korea. |
Pre-assignment Details |
Arm/Group Title | Initial Randomization: Immediate Start Linezolid | Initial Randomization: Delayed Start Linezolid | 2nd Randomization: Linezolid 600 mg Daily | 2nd Randomization: Linezolid 300 mg Daily |
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Upon completion of entry criteria, subjects immediately added linezolid 600 mg once daily to their ongoing TB treatment regimen. | Subjects continued their existing treatment regimen for 2 additional months after which linezolid 600 mg once daily was added. | After conversion to negative sputum smears (or receipt of 4 months of therapy), patients underwent a second randomization, stratified according to diabetes mellitus status, either to continue receiving linezolid at a dose of 600 mg per day or to receive a lower dose, 300 mg per day, for an additional 18 months or until therapy was stopped owing to side effects or laboratory abnormalities. | After conversion to negative sputum smears (or receipt of 4 months of therapy), patients underwent a second randomization, stratified according to diabetes mellitus status, either to continue receiving linezolid at a dose of 600 mg per day or to receive a lower dose, 300 mg per day, for an additional 18 months or until therapy was stopped owing to side effects or laboratory abnormalities. |
Period Title: Initial Randomization | ||||
Started | 21 [1] | 20 | 0 | 0 |
Included in MITT Analysis | 19 | 20 | 0 | 0 |
Completed | 19 | 20 | 0 | 0 |
Not Completed | 2 | 0 | 0 | 0 |
Reason Not Completed | ||||
Physician Decision | 2 | 0 | 0 | 0 |
[1]
2 patients withdrawn before receiving any linezolid owing to baseline neuropathy
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Period Title: Second Randomization | ||||
Started | 0 | 0 | 17 [1] | 16 [1] |
Completed | 0 | 0 | 17 | 16 |
Not Completed | 0 | 0 | 0 | 0 |
[1]
6 patients excluded before 2nd randomization: 2 had withdrawn and 4 already dose reduced due to AE
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Baseline Characteristics
Arm/Group Title | Immediate Start Linezolid | Delayed Start Linezolid | Total | |
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Upon completion of entry criteria, subjects will have LZD (600 mg once daily) added to their regimen. After 2 consecutive AFB negative sputum smears (or at 4 months) subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy. | Subjects will continue their existing regimen for 2 months after which LZD (600 mg once daily) will be added. After 2 consecutive AFB negative sputum smears (not to exceed 4 months of LZD therapy), subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy. | Total of all reporting groups | |
Overall Number of Baseline Participants | 19 | 20 | 39 | |
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2 patients excluded in immediate start group before receiving any linezolid owing to baseline neuropathy
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 19 participants | 20 participants | 39 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
19 100.0%
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20 100.0%
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39 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 19 participants | 20 participants | 39 participants | |
42.1 (11.2) | 40.4 (9.8) | 41.2 (10.4) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 19 participants | 20 participants | 39 participants | |
Female |
7 36.8%
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4 20.0%
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11 28.2%
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Male |
12 63.2%
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16 80.0%
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28 71.8%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Korea, Republic of | Number Analyzed | 19 participants | 20 participants | 39 participants |
19 | 20 | 39 |
Outcome Measures
Adverse Events
Limitations and Caveats
Small sample size
More Information
Results Point of Contact
Name/Title: | Dr. Clifton Barry |
Organization: | Tuberculosis Research Section, LCID, NIAID, NIH |
Phone: | 301-451-9554 |
EMail: | cbarry@niaid.nih.gov |
Other Publications:
Responsible Party: | Clifton E. Barry III, Ph.D., National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00727844 |
Other Study ID Numbers: |
08-I-N167 |
First Submitted: | August 1, 2008 |
First Posted: | August 4, 2008 |
Results First Submitted: | September 10, 2013 |
Results First Posted: | February 24, 2014 |
Last Update Posted: | March 14, 2016 |