TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB

Phase 1

Completed

• Conditions: Multi-drug Resistant Tuberculosis; Extensively Drug Resistant Tuberculosis
• Interventions: Drug: Linezolid; Drug: Placebo

• Registration Number: NCT00664313
• Lead Sponsor: Centers for Disease Control and Prevention

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 Description

Not available

Study Timeline

• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-04-21
• Study First Posted: 2008-04-22
• Study Start: 2009-04
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Linezolid	Linezolid	Linezolid 600 mg po QD
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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.	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.	within 18 weeks of treatment initiation

Secondary Outcome Measures

Name	Time	Method
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.	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	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	First 16 weeks of study therapy
The occurrence of treatment failure in the first 12 month following initiation of study therapy	first 12 months
Changes from baseline in assessments for peripheral neuropathy	First 12 months
Changes from baselines in Snellen or Jaeger visual acuity test and Ishihara color plate test results to assess for optic neuropathy	12 months

Trial Locations

Locations (1)

King George V Hospital; 🇿🇦 Durban, South Africa