Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for Osteomyelitis

• Status: Terminated
• Trial end date: 2017-02-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loyola University
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Aztreonam; Cefepime; Ciprofloxacin; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Daptomycin; Fluoroquinolones; Linezolid; Meropenem; Metronidazole; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Sulfamethoxazole; Tazobactam; Thienamycins; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination; Vancomycin

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]