Linezolid for the treatment of multidrug-resistant, gram-positive infections: experience from a compassionate-use program

Clin Infect Dis. 2003 Jan 15;36(2):159-68. doi: 10.1086/345744. Epub 2003 Jan 3.

Abstract

Linezolid was provided for treatment of multidrug-resistant, gram-positive infections through a compassionate-use program. Patients (n=796) received 600 mg of linezolid intravenously or orally every 12 h (828 treatment courses). Bacteremia was present in 46% of infections, endocarditis was present in 10.6%, and line-related infections were present in 31.1%. Other infections included intraabdominal infections (15.1%), complicated skin and skin-structure infections (13.3%), and osteomyelitis (10.7%). Causative pathogens included vancomycin-resistant enterococci (66.3%) and methicillin-resistant staphylococci (22.1%). Clinical intent-to-treat (ITT) outcomes in the evaluable population were as follows: cure, 73.3%; failure, 6.8%; and indeterminate, 19.9%. Microbiological ITT outcomes in evaluable patients were as follows: cure, 82.4%; failure, 14.1%; and indeterminate, 3.5%. At the test of cure assessment, the clinical cure and microbiological success rates were 91.5% and 85.8%, respectively. The most common adverse events possibly related to linezolid use were gastrointestinal disturbances (9.8% of cases), thrombocytopenia (7.4% of cases), decreased hemoglobin/hematocrit levels (4.1% of cases), and cutaneous reactions (4.0% of cases). Linezolid provided high rates of clinical cure and microbiological success in this complicated patient population, with very good overall tolerance.

Publication types

  • Clinical Trial
  • Controlled Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetamides / adverse effects
  • Acetamides / therapeutic use*
  • Adolescent
  • Adult
  • Aged
  • Anti-Infective Agents / adverse effects
  • Anti-Infective Agents / therapeutic use*
  • Drug Interactions
  • Drug Resistance, Bacterial
  • Drug Resistance, Multiple
  • Female
  • Gram-Positive Bacterial Infections / drug therapy*
  • Humans
  • Linezolid
  • Male
  • Middle Aged
  • Oxazolidinones / adverse effects
  • Oxazolidinones / therapeutic use*
  • Treatment Outcome

Substances

  • Acetamides
  • Anti-Infective Agents
  • Oxazolidinones
  • Linezolid