NCT00664313

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Multi-drug Resistant Tuberculosis
• Extensively Drug Resistant Tuberculosis

Interventions

Type	Name	Description
DRUG	Linezolid	600 mg po daily for 112 doses (16 weeks)
DRUG	Placebo	Placebo given daily for 112 doses (16 weeks)

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2008-04-22
• Last updated: 2025-04-24

Locations

1 site across 1 country: South Africa