Could a lower dose of an old antibiotic tame Drug-Resistant TB?

NCT ID NCT00664313

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study tests whether a low daily dose of the antibiotic linezolid, added to a personalized combination of other drugs, is safe and tolerable for people with multidrug-resistant tuberculosis (MDR-TB). Participants take either linezolid or a placebo for 16 weeks, alongside their regular treatment. The goal is to see if this approach can help control the infection with fewer side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Linezolid (Zyvox)
What this could lead to
If successful, this could provide a safer, more tolerable treatment option for people with drug-resistant tuberculosis.
What could go wrong
This is an early-phase pilot study with only 36 participants, so results may not apply broadly. Linezolid can cause serious side effects like bone marrow suppression and nerve damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

36 people

The number who actually took part.

Start date

Apr 2009

Finished

Sep 2010

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. 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). 2. A documented positive sputum culture result for M. tuberculosis from a sputum obtained in the four months prior to enrollment. 3. 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. 4. Residence within the Durban Functional Region (Durban Metropolitan Area) or Tugela Ferry, Msinga District, KZN, RSA. 5. Age ≥ 18 years. 6. Karnofsky score of \> 50 (see section 18.1) 7. Willingness by the patient to attend scheduled follow-up visits and undergo study assessments. 8. 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) 9. Laboratory parameters done within 14 days prior to screening: 1. Serum creatinine level \< 2 times upper limit of normal 2. Hemoglobin level ≥ 9.0 g/dL 3. Platelet count of ≥ 80,000/mm3 4. Absolute neutrophil count (ANC) \> 1000/ mm3 5. Negative pregnancy test (for women of childbearing potential) 10. Able to provide informed consent or legally authorized representative able to do so if decisionally impaired. Exclusion Criteria 1. Currently breast-feeding or pregnant. 2. Known allergy or intolerance to linezolid. 3. 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. 4. Significant peripheral neuropathy as evidenced by \< 5 seconds of vibratory sense to a 128 Hz tuning fork on either big toe 5. Pain, aching or burning of the feet that interfere with walking or sleep. 6. In the judgment of the physician the patient is not expected to survive for more than 4 weeks. 7. Anticipated surgical intervention for the treatment of pulmonary tuberculosis 8. Visual acuity of 20/200 (6/60 meters) best corrected vision or less. 9. Poor color vision as evidenced by incorrect answers on \> four of 12 screening Ishihara plates 10. Participation in another drug trial. 11. 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)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Extensively drug-resistant tuberculosis are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • King George V Hospital

    Durban, South Africa

More trials for these conditions

Other studies related to the condition(s) this trial covers.