Linezolid in the treatment of osteomyelitis: results of compassionate use experience.
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.


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.


CONCLUSIONS
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.
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
C R
CR
Rayner
L M
LM
Baddour
M C
MC
Birmingham
C
C
Norden
A K
AK
Meagher
J J
JJ
Schentag
D000081:Acetamides / Q000008:administration & dosage* / Q000009:adverse effects; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D024881:Drug Resistance, Bacterial; D005260:Female; D005500:Follow-Up Studies; D016908:Gram-Positive Bacterial Infections / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D007275:Injections, Intravenous; D000069349:Linezolid; D008297:Male; D008875:Middle Aged; D010019:Osteomyelitis / Q000188:drug therapy* / Q000382:microbiology; D023303:Oxazolidinones / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016896:Treatment Outcome
D000081:Acetamides; D023303:Oxazolidinones; D000069349:Linezolid