Document Detail


Linezolid in the treatment of osteomyelitis: results of compassionate use experience.
MedLine Citation:
PMID:  15007736     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
C R Rayner; L M Baddour; M C Birmingham; C Norden; A K Meagher; J J Schentag
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Infection     Volume:  32     ISSN:  0300-8126     ISO Abbreviation:  Infection     Publication Date:  2004 Feb 
Date Detail:
Created Date:  2004-03-09     Completed Date:  2004-04-15     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0365307     Medline TA:  Infection     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  8-14     Citation Subset:  IM    
Affiliation:
Facility for Anti-infective Drug Development and Innovation, Victorian College of Pharmacy, Monash University, 381 Royal Parade, 3052, Parkville, VIC, Australia. craig.rayner@vcp.monash.edu.au
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MeSH Terms
Descriptor/Qualifier:
Acetamides / administration & dosage*,  adverse effects
Administration, Oral
Adult
Aged
Aged, 80 and over
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Resistance, Bacterial
Female
Follow-Up Studies
Gram-Positive Bacterial Infections / diagnosis,  drug therapy*
Humans
Injections, Intravenous
Male
Middle Aged
Osteomyelitis / drug therapy*,  microbiology
Oxazolidinones / administration & dosage*,  adverse effects
Prospective Studies
Risk Assessment
Severity of Illness Index
Single-Blind Method
Treatment Outcome
Chemical
Reg. No./Substance:
0/Acetamides; 0/Oxazolidinones; 165800-03-3/linezolid

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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