Methods: We are conducting an open label single-center trial of oral tedizolid for the treatment of BJIs. The primary outcome of this study is patient safety. Patients are eligible if they have a BJI caused by documented or suspected gram positive pathogen and require at least 4 weeks of therapy (up to 12 weeks). Enrolled patients undergo weekly monitoring for neurologic and visual, side effects and weekly hematologic and comprehensive chemistry panel lab monitoring. Patients with peripheral neuropathy and cytopenias are excluded from participation.
Results: To date, we have enrolled 19 subjects (17 (89%) male) with BJIs (11 (58%) hardware associated infection, 5 (26%) osteomyelitis without prosthesis, 3 (16%) prosthetic joint infection). Significant co-morbidities include 6 (32%) with diabetes and 1 (5%) with systemic lupus. Fourteen (74%) patients have completed therapy, 2 (11%) remain on therapy, 1 (5%) withdrew from the study, and 2 (11%) were lost to follow up. Mean (median) duration of treatment has been 9.7 (11) weeks with a range of 4-12 weeks. Significant drug-related adverse events occurred in 2 patients (11%), both with non-life threatening maculopapular rashes, one of whom required treatment discontinuation. To date, there have been 10/14 (71%) treatment successes. Failures have been associated with previously undetected retained hardware (n=1), sequestrum requiring surgery (n=1), and failure to achieve cure after the designated treatment course (n=2). There have been no cases of cytopenias, peripheral or optic neuropathy.
Conclusion: Tedizolid appears to be a well tolerated oral antibiotic for treatment of bone and joint infections for 4 weeks or greater. Clinical failure rates appear roughly similar to that of other oral options. Further study of tedizolid for BJIs is warranted.
M. Kuvhenguhwa, None
T. Kim, None
K. Derrah, None
L. G. Miller, Merck: Grant Investigator , Research grant .