TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB (NCT00664313) | Clinical Trial Compass
CompletedPhase 1/2
TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB
South Africa36 participantsStarted 2009-04
Plain-language summary
The antibiotic linezolid when given for the treatment of multi-drug resistant tuberculosis is safe and tolerated at a low dose (600 mg daily) for a limited duration (16 weeks)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)
✓. 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)
Exclusion criteria
✕. 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.
What they're measuring
1
Cumulative rate of serious adverse events - SAEs (measured as the number of SAEs per person days) during the period of study therapy and the four weeks of post-study therapy follow-up.
Timeframe: the period of study therapy (generally 16 weeks) plus the four weeks of post-study therapy follow-up.
2
Proportion of patients in each arm who complete 80% of the proposed regimen (90 doses) within 18 weeks of treatment initiation.
Timeframe: within 18 weeks of treatment initiation