Multi-drug Resistant TuberculosisPhase 1/2LiMiTNCT00664313
TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB
A Phase 1/2 study testing Linezolid in people with Multi-drug Resistant Tuberculosis and Extensively Drug Resistant Tuberculosis, run by Centers for Disease Control and Prevention at 1 site in South Africa.
Trial summary
This study evaluated the safety and tolerability of low-dose linezolid (600 mg once daily) administered for 16 weeks as part of an optimized background regimen for the treatment of multidrug-resistant tuberculosis (MDR-TB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multi-drug Resistant Tuberculosis, Extensively Drug Resistant Tuberculosis
- What is being tested?
- Linezolid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSouth Africa
- Study dates
- Apr 2009to Sep 2010
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pulmonary tuberculosis with or without extrapulmonary TB with a M. tuberculosis isolate that is confirmed to be resistant to at least rifampin and isoniazid (without regard to prior treatment for TB).
- A documented positive sputum culture result for M. tuberculosis from a sputum obtained in the four months prior to enrollment.
- Willingness to have HIV testing performed, if HIV serostatus is not known or if the last documented negative HIV test was more than 6 months prior to enrollment.
- Residence within the Durban Functional Region (Durban Metropolitan Area) or Tugela Ferry, Msinga District, KZN, RSA.
- Age ≥ 18 years.
- Karnofsky score of > 50 (see section 18.1)
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- Willingness by the patient to attend scheduled follow-up visits and undergo study assessments.
- Women with child-bearing potential must agree to practice an adequate method of birth control or to abstain from heterosexual intercourse during study therapy. (Standard birth control measures are provided free of charge by public health institutions)
- Laboratory parameters done within 14 days prior to screening:
- Serum creatinine level < 2 times upper limit of normal
- Hemoglobin level ≥ 9.0 g/dL
- Platelet count of ≥ 80,000/mm3
- Absolute neutrophil count (ANC) > 1000/ mm3
- Negative pregnancy test (for women of childbearing potential)
- Able to provide informed consent or legally authorized representative able to do so if decisionally impaired.
Who cannot join
- Currently breast-feeding or pregnant.
- Known allergy or intolerance to linezolid.
- Planned therapy during the intensive phase of tuberculosis treatment using drugs having unacceptable interactions with linezolid, including dopamine, selective serotonin uptake inhibitors (citalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline), amitriptyline, bupropion, mirtazepine, levodopa, carbidopa, sinemet, or herbal medications.
- Significant peripheral neuropathy as evidenced by < 5 seconds of vibratory sense to a 128 Hz tuning fork on either big toe
- Pain, aching or burning of the feet that interfere with walking or sleep.
- In the judgment of the physician the patient is not expected to survive for more than 4 weeks.
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- Anticipated surgical intervention for the treatment of pulmonary tuberculosis
- Visual acuity of 20/200 (6/60 meters) best corrected vision or less.
- Poor color vision as evidenced by incorrect answers on > four of 12 screening Ishihara plates
- Participation in another drug trial.
- The patient has received second line TB drugs for > 7 days immediately prior to enrollment (note: use of first line drugs such as INH, Rifampin, PZA, or ethambutol for > 7 days immediately prior to enrollment is allowed)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TBTC Study 30: A Phase I/II Pilot Study for Evaluation of Low Dose, Once Daily, Linezolid Plus Optimized Background Therapy (OBT) Versus Placebo Plus OBT for the Treatment of Multi-drug Resistant Tuberculosis
This study evaluated the safety and tolerability of low-dose linezolid (600 mg once daily) administered for 16 weeks as part of an optimized background regimen for the treatment of multidrug-resistant tuberculosis (MDR-TB).
Read the detailed description
Tuberculosis Trials Consortium (TBTC) Study 30 was a randomized, double-blind, placebo-controlled Phase I/II clinical trial conducted to evaluate the safety and tolerability of low-dose linezolid when added to an optimized background regimen for the treatment of multidrug-resistant (MDR) or extensively drug-resistant (XDR) tuberculosis.
Participants received either linezolid 600 mg orally once daily or matching placebo for 16 weeks in addition to background therapy consisting of at least four drugs with presumed activity against Mycobacterium tuberculosis.
The primary objectives were to assess tolerability, defined as the proportion of participants completing at least 80% of planned doses within 18 weeks, and safety, assessed by the occurrence of serious adverse events during treatment and a 4-week follow-up period.
Secondary assessments included adverse event profiles, laboratory safety parameters, and time to sputum culture conversion.
The study was conducted in Durban, South Africa, among adults with confirmed MDR or XDR tuberculosis.
- Being tested
- Linezolid, Placebo
- Keywords
- Linezolid, Zyvox, Peripheral Neuropathy, Optic Neuropathy, Anemia, Thrombocytopenia
- Medical subject headings
- Tuberculosis, Multidrug-Resistant, Extensively Drug-Resistant Tuberculosis, Peripheral Nervous System Diseases, Optic Nerve Diseases, Anemia, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinezolidDrug
Also called Zyvox
600 mg po daily for 112 doses (16 weeks)
PlaceboDrug
Also called PH-102 Avicel (96%), Explotab sodium starch glycolate (3%), and Magnesium stearate (1%)
Placebo given daily for 112 doses (16 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Linezolid | Experimental | Linezolid 600 mg po QD Receives: Drug: Linezolid |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Completing at Least 80% (≥90 of 112) of Assigned Study Drug Doses Within 18 Weeks
Proportion of participants who completed at least 80% (≥90 of 112 doses) of directly observed study drug within 18 weeks of treatment initiation.
Measured: 18 weeks
Number of Serious Adverse Events During Study Drug Therapy and 4 Weeks Post-Therapy
Number of serious adverse events occurring during study drug therapy and the 4 weeks after completion of study therapy.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startApr 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multi-drug Resistant TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- University of KwaZulu, Columbia University, Yale University
- Responsible party
- Sponsor
- Investigators
- Jussi Saukkonen, MD, Principal investigator, Boston UniversityWaffa El-Sadr, MD, Principal investigator, Columbia UniversityNesri Padayachin, MBChB, Principal investigator, University of Kwa-Zulu Natal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664313
- Sponsor's protocol ID
- CDC-NCHHSTP-5356
- Acronym
- LiMiT
- Status last verified
- Jun 2026
- First submitted
- 18 Apr 2008
- Last updated
- 6 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Padayatchi N, Mac Kenzie WR, Hirsch-Moverman Y, Feng PJ, Villarino E, Saukkonen J, Heilig CM, Weiner M, El-Sadr WM. Lessons from a randomised clinical trial for multidrug-resistant tuberculosis. Int J Tuberc Lung Dis. 2012 Dec;16(12):1582-7. doi: 10.5588/ijtld.12.0315.
PubMed 23131255
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TBTC Study 30: A Phase I/II Pilot Study for Evaluation of Low Dose, Once Daily, Linezolid Plus Optimized Background Therapy (OBT) Versus Placebo Plus OBT for the Treatment of Multi-drug Resistant Tuberculosis
- ClinicalTrials.gov ID
- NCT00664313
- Acronym / sponsor ID
- LiMiT / CDC-NCHHSTP-5356
- Keywords
- Linezolid, Zyvox, Peripheral Neuropathy, Optic Neuropathy, Anemia, Thrombocytopenia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- University of KwaZulu, Columbia University, Yale University
- Study start
- Apr 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Posted 6 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the safety and tolerability of low-dose linezolid (600 mg once daily) administered for 16 weeks as part of an optimized background regimen for the treatment of multidrug-resistant tuberculosis (MDR-TB).
Detailed description
Tuberculosis Trials Consortium (TBTC) Study 30 was a randomized, double-blind, placebo-controlled Phase I/II clinical trial conducted to evaluate the safety and tolerability of low-dose linezolid when added to an optimized background regimen for the treatment of multidrug-resistant (MDR) or extensively drug-resistant (XDR) tuberculosis.
Participants received either linezolid 600 mg orally once daily or matching placebo for 16 weeks in addition to background therapy consisting of at least four drugs with presumed activity against Mycobacterium tuberculosis.
The primary objectives were to assess tolerability, defined as the proportion of participants completing at least 80% of planned doses within 18 weeks, and safety, assessed by the occurrence of serious adverse events during treatment and a 4-week follow-up period.
Secondary assessments included adverse event profiles, laboratory safety parameters, and time to sputum culture conversion.
The study was conducted in Durban, South Africa, among adults with confirmed MDR or XDR tuberculosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linezolid | Experimental | Drug: LinezolidLinezolid 600 mg po QD |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Pulmonary tuberculosis with or without extrapulmonary TB with a M. tuberculosis isolate that is confirmed to be resistant to at least rifampin and isoniazid (without regard to prior treatment for TB).
- A documented positive sputum culture result for M. tuberculosis from a sputum obtained in the four months prior to enrollment.
- Willingness to have HIV testing performed, if HIV serostatus is not known or if the last documented negative HIV test was more than 6 months prior to enrollment.
- Residence within the Durban Functional Region (Durban Metropolitan Area) or Tugela Ferry, Msinga District, KZN, RSA.
- Age ≥ 18 years.
Key exclusion criteria (11 listed)
- Currently breast-feeding or pregnant.
- Known allergy or intolerance to linezolid.
- Planned therapy during the intensive phase of tuberculosis treatment using drugs having unacceptable interactions with linezolid, including dopamine, selective serotonin uptake inhibitors (citalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline), amitriptyline, bupropion, mirtazepine, levodopa, carbidopa, sinemet, or herbal medications.
- Significant peripheral neuropathy as evidenced by < 5 seconds of vibratory sense to a 128 Hz tuning fork on either big toe
- Pain, aching or burning of the feet that interfere with walking or sleep.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LinezolidAlso: Zyvox600 mg po daily for 112 doses (16 weeks) | Drug | Linezolid |
| PlaceboAlso: PH-102 Avicel (96%), Explotab sodium starch glycolate (3%), and Magnesium stearate (1%)Placebo given daily for 112 doses (16 weeks) | Drug | Placebo |
Primary outcome
Participants Completing at Least 80% (≥90 of 112) of Assigned Study Drug Doses Within 18 Weeks
Time frame: 18 weeks
Proportion of participants who completed at least 80% (≥90 of 112 doses) of directly observed study drug within 18 weeks of treatment initiation.
Number of Serious Adverse Events During Study Drug Therapy and 4 Weeks Post-Therapy
Time frame: 20 weeks
Number of serious adverse events occurring during study drug therapy and the 4 weeks after completion of study therapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23131255Padayatchi N, Mac Kenzie WR, Hirsch-Moverman Y, Feng PJ, Villarino E, Saukkonen J, Heilig CM, Weiner M, El-Sadr WM. Lessons from a randomised clinical trial for multidrug-resistant tuberculosis. Int J Tuberc Lung Dis. 2012 Dec;16(12):1582-7. doi: 10.5588/ijtld.12.0315.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jussi Saukkonen, MD principal investigator
Boston University
Waffa El-Sadr, MD principal investigator
Columbia University
Nesri Padayachin, MBChB principal investigator
University of Kwa-Zulu Natal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Linezolid in people with Multi-drug Resistant Tuberculosis and Extensively Drug Resistant Tuberculosis, run by Centers for Disease Control and Prevention at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Completing at Least 80% (≥90 of 112) of Assigned Study Drug Doses Within 18 Weeks (time frame: 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00664313, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.