Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for Osteomyelitis
Condition: Osteomyelitis
MeSH terms: Osteomyelitis
Intervention: Intravenous Antibacterial Agent; Oral Antibacterial Agent
Intervention description: Individuals in this arm receive an intravenous antibacterial agent. They are not assigned to specific medications. Individuals in this arm will receive an intravenous antibacterial agent as determined by their primary healthcare provider. This therapy is usually one of the following intravenous medications: (i) piperacillin/tazobactam (Zosyn), (ii) cefepime, (iii) metronidazole, (iv) aztreonam, (v) vancomycin, (vi) daptomycin, (vii) linezolid (Zyvox), and/or (viii) meropenem.; Individuals in this arm receive an oral antibacterial agent. They are not assigned to specific medications. Individuals in this arm will receive an oral antibacterial agent as determined by their primary healthcare provider. This therapy is usually one of the following oral medications: (i) sulfamethoxazole/trimethoprim (SMX-TMP), (ii) clindamycin (Clindesse), (iii) linezolid (Zyvox), (iv) moxifloxacin (Avelox), (v) ciprofloxacin (Cetraxal), and/or (vi) metronidazole (Flagyl)
Intervention MeSH terms: Moxifloxacin; Metronidazole; Vancomycin; Ciprofloxacin; Clindamycin; Meropenem; Tazobactam; Linezolid; Piperacillin; Daptomycin; Cefepime; Piperacillin, Tazobactam Drug Combination; Aztreonam; Anti-Bacterial Agents; Trimethoprim, Sulfamethoxazole Drug Combination; Trimethoprim; Sulfamethoxazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Osteomyelitis; Diabetes; Foot Infection

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age and older

          -  Diagnosis of Diabetes Mellitus (per past medical history documented in the patient
             medical record)

          -  Foot osteomyelitis (distal to ankle)

          -  Surgical debridement (in operating room)

        Exclusion Criteria:

          -  Absolute neutrophil count (ANC) < 500

          -  Pregnant or lactating patients

          -  Patients with organisms resistant to oral therapy

          -  Internal hardware

          -  Definitive amputations (BKA)

          -  Limb ischemia [absent pedal pulses or ankle-brachial index (ABI) < 0.5]