Advertisement

Infection

, Volume 32, Issue 1, pp 8–14 | Cite as

Linezolid in the Treatment of Osteomyelitis: Results of Compassionate Use Experience

  • C. R. Rayner
  • L. M. Baddour
  • M. C. Birmingham
  • C. Norden
  • A. K. Meagher
  • J. J. Schentag
Clinical and Epidemiological Study

Abstract.

Background:

This case series examines osteomyelitis patients enrolled into a prospective, open label, noncomparative, non-randomized compassionate use program. Patients received 600 mg bid iv or po linezolid.

Patients and Methods:

89 patients were enrolled into the compassionate use program with the diagnosis of osteomyelitis and were evaluated for clinical efficacy, safety and tolerability. Informed consent was obtained from the patients or their guardians and guidelines for human experimentation of the US Department of Health and Human Services and/or those of the investigators’ institutions were followed in the conduct of this clinical research.

Results:

55 cases of osteomyelitis met the inclusion criteria for clinical assessment. The 55 courses included long bone (53%), diabetic foot (18%), sternal wound (14.5%) and vertebral osteomyelitis (15%). Clinical assessment at longterm follow-up occurred at a median of 195 days after the last dose, and the clinical cure rate in 22 evaluable cases was 81.8% and failure rate 18.2%. The most common clinical adverse drug events (ADEs) were gastrointestinal disturbances. Reduction in hemoglobin/hematocrit and in platelet counts were the most common laboratory ADEs.

Conclusion:

Linezolid iv or po was successful in treating patients with osteomyelitis caused by resistant grampositive organisms or those with intolerance or nonresponsiveness to other potentially effective treatments. Larger comparator controlled studies should be performed to confirm these findings.

Keywords

Platelet Count Failure Rate Clinical Assessment Drug Event Osteomyelitis 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

Copyright information

© Urban & Vogel Medien und Medizin Verlagsgesellschaft 2004

Authors and Affiliations

  • C. R. Rayner
    • 1
  • L. M. Baddour
    • 3
  • M. C. Birmingham
    • 4
  • C. Norden
    • 5
  • A. K. Meagher
    • 6
  • J. J. Schentag
    • 2
  1. 1.Facility for Anti-infective Drug Development and Innovation, Victorian College of PharmacyMonash UniversityParkvilleAustralia
  2. 2.The University at Buffalo Clinical Pharmacokinetics LaboratoryBuffaloUSA
  3. 3.Mayo ClinicRochesterUSA
  4. 4.Infectious Diseases ConsultantBuffaloUSA
  5. 5.PharmaciaKalamazooUSA
  6. 6.SUNY at Buffalo Clinical Pharmacokinetics LaboratoryAmherstUSA

Personalised recommendations