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Linezolid Pharmacokinetics (PK) in Multi-Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) Tuberculosis (TB) — S30PK  

Multi-Drug Resistant Tuberculosis Clinical Trial

Official title:
Linezolid Pharmacokinetics and Pharmacodynamics in the Treatment of Multi-Drug Resistant and Extensively-Drug Resistant Tuberculosis

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
Clinical Trial Details
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
View Details
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