Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for Osteomyelitis
Status:
Terminated
Trial end date:
2017-02-02
Target enrollment:
Participant gender:
Summary
The Infectious Diseases Society of America (IDSA) 2012 guidelines for the diagnosis and
treatment of diabetic foot infections state that for the treatment of diabetic foot
osteomyelitis "No data support the superiority of any specific antibiotic agent or treatment
strategy, route, or duration of therapy." Traditionally, osteomyelitis has been treated with
a long course of intravenous antibiotics, generally six weeks. Oral antibiotics with high
bioavailability and adequate bone penetration have been shown in published studies to be
effective for the treatment of osteomyelitis.
The investigators propose to conduct a prospective, single-center, randomized, open trial at
Loyola University Medical Center (LUMC) comparing the efficacy of oral antibiotic therapy to
intravenous (IV) antibiotic therapy for the treatment of diabetic foot osteomyelitis. The
investigators hypothesize that oral antibiotic therapy is equivalent to IV antibiotic
therapy. Bone/tissue cultures are obtained for all patients for clinical purposes and are
sent to pathology for histologic examination and to the clinical microbiology laboratory for
culture and susceptibility. Patients will receive six weeks of IV or oral antibiotic therapy
depending upon their randomization group. Primary outcomes at six months clinical follow-up
will include: (i) no evidence of bone infection and (ii) resolution of ulcer.