Clinical Trial: TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Tube
Brief 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)
Detailed Summary:
Sponsor: Centers for Disease Control and Prevention
Current Primary Outcome:
- 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. [ Time Frame: the period of study therapy (generally 16 weeks) plus the four weeks of post-study therapy follow-up. ]
- Proportion of patients in each arm who complete 80% of the proposed regimen (90 doses) within 18 weeks of treatment initiation. [ Time Frame: within 18 weeks of treatment initiation ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The number of days required to convert to culture negative status in sputum of those in each treatment arm on solid and liquid media, respectively. [ Time Frame: first 16 weeks of study therapy ]
- The proportion of culture-negative patients during the first 16 weeks of therapy (at two week intervals) of linezolid with OBT vs. that of OBT with placebo on solid and liquid media, respectively [ Time Frame: first 16 weeks of study therapy ]
- Time to detection of M. tuberculosis on MGIT for each positive culture for sputum specimens collected every 2 weeks during the first 16 weeks of therapy [ Time Frame: First 16 weeks of study therapy ]
- The occurrence of treatment failure in the first 12 month following initiation of study therapy [ Time Frame: first 12 months ]
- Changes from baseline in assessments for peripheral neuropathy [ Time Frame: First 12 months ]
- Changes from baselines in Snellen or Jaeger visual acuity test and Ishihara color plate test results to assess for optic neuropathy [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Centers for Disease Control and Prevention
Dates:
Date Received: April 18, 2008
Date Started: April 2009
Date Completion:
Last Updated: October 1, 2012
Last Verified: October 2012