Trial Outcomes & Findings for TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB (NCT NCT00664313)
NCT ID: NCT00664313
Last Updated: 2026-07-06
Results Overview
Proportion of participants who completed at least 80% (≥90 of 112 doses) of directly observed study drug within 18 weeks of treatment initiation.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
18 weeks
Results posted on
2026-07-06
Participant Flow
Thirty-six participants were enrolled and randomized. Two participants were not included in the participant flow analysis population: one participant withdrew before receiving any study drug, and one participant was determined to be ineligible after enrollment and was withdrawn from the study. Therefore, 34 participants received at least one dose of study drug and are included in the Participant Flow module.
Participant milestones
| Measure |
Linezolid
Linezolid 600 mg orally once daily for 16 weeks (112 doses) added to optimized background therapy (OBT).
|
Placebo
Matching placebo once daily for 16 weeks added to optimized background therapy (OBT).
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
18
|
|
Overall Study
COMPLETED
|
11
|
14
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Linezolid
Linezolid 600 mg orally once daily for 16 weeks (112 doses) added to optimized background therapy (OBT).
|
Placebo
Matching placebo once daily for 16 weeks added to optimized background therapy (OBT).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
Baseline Characteristics
TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB
Baseline characteristics by cohort
| Measure |
Linezolid
n=16 Participants
Linezolid 600 mg po QD
Linezolid: 600 mg po daily for 112 doses (16 weeks)
|
Placebo
n=18 Participants
Placebo
Placebo: Placebo given daily for 112 doses (16 weeks)
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
n=9 Participants
|
34 years
n=27 Participants
|
36 years
n=267 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
14 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
20 Participants
n=267 Participants
|
|
HIV Status
HIV Positive
|
9 participants
n=9 Participants
|
15 participants
n=27 Participants
|
24 participants
n=267 Participants
|
|
HIV Status
HIV Negative
|
7 participants
n=9 Participants
|
3 participants
n=27 Participants
|
10 participants
n=267 Participants
|
PRIMARY outcome
Timeframe: 18 weeksProportion of participants who completed at least 80% (≥90 of 112 doses) of directly observed study drug within 18 weeks of treatment initiation.
Outcome measures
| Measure |
Placebo
n=18 Participants
Matching placebo once daily for 16 weeks added to optimized background therapy (OBT).
|
Linezolid
n=16 Participants
Linezolid 600 mg orally once daily for 16 weeks (112 doses) added to optimized background therapy (OBT).
|
|---|---|---|
|
Participants Completing at Least 80% (≥90 of 112) of Assigned Study Drug Doses Within 18 Weeks
|
14 participants
|
11 participants
|
PRIMARY outcome
Timeframe: 20 weeksPopulation: Participants who received at least one dose of study drug and were evaluable for safety.
Number of serious adverse events occurring during study drug therapy and the 4 weeks after completion of study therapy.
Outcome measures
| Measure |
Placebo
n=18 Participants
Matching placebo once daily for 16 weeks added to optimized background therapy (OBT).
|
Linezolid
n=16 Participants
Linezolid 600 mg orally once daily for 16 weeks (112 doses) added to optimized background therapy (OBT).
|
|---|---|---|
|
Number of Serious Adverse Events During Study Drug Therapy and 4 Weeks Post-Therapy
|
1 serious adverse events
|
0 serious adverse events
|
Adverse Events
Linezolid
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Linezolid
n=16 participants at risk
Linezolid 600 mg orally once daily for 16 weeks (112 doses) added to optimized background therapy (OBT).
|
Placebo
n=18 participants at risk
Matching placebo once daily for 16 weeks added to optimized background therapy (OBT).
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/16 • 20 weeks
Adverse events were collected during the 16-week study drug treatment period and for 4 weeks following completion of study therapy.
|
5.6%
1/18 • 20 weeks
Adverse events were collected during the 16-week study drug treatment period and for 4 weeks following completion of study therapy.
|
Other adverse events
| Measure |
Linezolid
n=16 participants at risk
Linezolid 600 mg orally once daily for 16 weeks (112 doses) added to optimized background therapy (OBT).
|
Placebo
n=18 participants at risk
Matching placebo once daily for 16 weeks added to optimized background therapy (OBT).
|
|---|---|---|
|
Nervous system disorders
Peripheral neuropathy
|
31.2%
5/16 • Number of events 5 • 20 weeks
Adverse events were collected during the 16-week study drug treatment period and for 4 weeks following completion of study therapy.
|
5.6%
1/18 • Number of events 1 • 20 weeks
Adverse events were collected during the 16-week study drug treatment period and for 4 weeks following completion of study therapy.
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Number of events 1 • 20 weeks
Adverse events were collected during the 16-week study drug treatment period and for 4 weeks following completion of study therapy.
|
11.1%
2/18 • Number of events 2 • 20 weeks
Adverse events were collected during the 16-week study drug treatment period and for 4 weeks following completion of study therapy.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • 20 weeks
Adverse events were collected during the 16-week study drug treatment period and for 4 weeks following completion of study therapy.
|
11.1%
2/18 • Number of events 2 • 20 weeks
Adverse events were collected during the 16-week study drug treatment period and for 4 weeks following completion of study therapy.
|
|
General disorders
Induration
|
62.5%
10/16 • Number of events 10 • 20 weeks
Adverse events were collected during the 16-week study drug treatment period and for 4 weeks following completion of study therapy.
|
61.1%
11/18 • Number of events 11 • 20 weeks
Adverse events were collected during the 16-week study drug treatment period and for 4 weeks following completion of study therapy.
|
Additional Information
William R. Mac Kenzie, MD
Centers for Disease Control and Prevention
Phone: 404-639-4000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place