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Clinical Trial Summary

This is a one-period, double-blind, single-center pharmacokinetic study of linezolid in patients with MDR or XDR tuberculosis treated with linezolid and an Optimized Background Therapy (defined as treatment with > 4 drugs with activity against tuberculosis to which the patient's isolate is believed to be sensitive by history or based on drug sensitivity testing).


Clinical Trial Description

This is a one-period, double-blind, single-center pharmacokinetic study of linezolid in patients with MDR or XDR tuberculosis treated with linezolid and an Optimized Background Therapy (defined as treatment with > 4 drugs with activity against tuberculosis to which the patient's isolate is believed to be sensitive by history or based on drug sensitivity testing). ;


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Extensively Drug Resistant Tuberculosis
  • Extensively Drug-Resistant Tuberculosis
  • Multi-Drug Resistant Tuberculosis
  • Tuberculosis
  • Tuberculosis, Multidrug-Resistant

NCT number NCT00691392
Study type Interventional
Source Centers for Disease Control and Prevention
Contact
Status Completed
Phase Phase 1/Phase 2
Start date April 2009
Completion date May 2010

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