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临床试验/NCT02168816
NCT02168816终止2 期

Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for the Treatment of Diabetic Foot Osteomyelitis (CRO-OSTEOMYELITIS)

Loyola University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年3月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
发起方
入组人数
30
试验地点
1
主要终点
Number of Participants With Bone Infection

研究概览

简要总结

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.

详细描述

Currently, available literature is not adequate to determine the best agent, route, or duration of antibiotic therapy for the treatment of chronic osteomyelitis. The standard of therapy has been to treat patients with a parenteral antibiotic for four to six weeks. In a recent literature review by Spellberg et al. it was concluded that oral and parenteral antibiotic therapy have similar cure rates for the treatment of chronic osteomyelitis. Oral antibiotic therapy is associated with a lower risk to the patient due to avoiding the need of a central IV line. Additionally, oral therapy costs less than a course of IV antibiotics. Oral antibiotics with high bioavailability and good bone penetration include, fluoroquinolones, linezolid, trimethoprim/sulfamethoxazole (2 tabs bid), clindamycin and metronidazole. These antibiotics have been shown in recent studies to obtain levels in the bone that exceed the minimum inhibitory concentration (MIC) levels of the targeted organisms. According to the IDSA 2012 guidelines for the treatment of diabetic foot infections, the diagnosis of osteomyelitis can be made via plain radiographs or MRI imaging (more sensitive). A bone scan can be considered if an MRI cannot be done. The preferred method of diagnosis is by bone culture and histology. The guidelines also recommend surgical debridement to healthy tissue for diabetic foot infections followed by antibiotic therapy.

The Purpose of this study is to compare the efficacy of oral antibiotic therapy with intravenous antibiotic therapy for the treatment of diabetic foot osteomyelitis following surgical debridement. They hypothesis is that oral antibiotic therapy is equivalent to intravenous antibiotic therapy for the treatment of diabetic foot osteomyelitis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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]

研究组 & 干预措施

Midfoot

Active Comparator

Individuals with an infection on the midfoot are randomized to an intravenous antibacterial agent or an oral antibacterial agent.

干预措施: Intravenous Antibacterial Agent (Drug)

Midfoot

Active Comparator

Individuals with an infection on the midfoot are randomized to an intravenous antibacterial agent or an oral antibacterial agent.

干预措施: Oral Antibacterial Agent (Drug)

Hindfoot

Active Comparator

Individuals with an infection on the hindfoot are randomized to an intravenous antibacterial agent or an oral antibacterial agent.

干预措施: Intravenous Antibacterial Agent (Drug)

Hindfoot

Active Comparator

Individuals with an infection on the hindfoot are randomized to an intravenous antibacterial agent or an oral antibacterial agent.

干预措施: Oral Antibacterial Agent (Drug)

Toe

Active Comparator

Individuals with an infection on the toe are randomized to an intravenous antibacterial agent or an oral antibacterial agent.

干预措施: Intravenous Antibacterial Agent (Drug)

Toe

Active Comparator

Individuals with an infection on the toe are randomized to an intravenous antibacterial agent or an oral antibacterial agent.

干预措施: Oral Antibacterial Agent (Drug)

结局指标

主要结局

Number of Participants With Bone Infection

时间窗: Six Months

Six months following completion of treatment, the researchers record evidence of bone infection for each participant. A negative diagnosis is made when there is (i) an absence of infection based on clinical examination and (ii) down-trending of inflammatory markers. Otherwise, a positive diagnosis is made.

次要结局

  • Number of Participants With Ulcer Resolution(Six Months)

研究者

发起方
Loyola University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Pinzur, M.D.

Professor

Loyola University

研究点 (1)

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