PO Versus IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 16
- 主要终点
- Number of patients with a hospital re-admission
研究概览
简要总结
This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.
详细描述
This is a Phase III clinical randomized control trial to investigate differences between patients with infected unhealed fracture treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected unhealed fracture after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected unhealed fracture after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, timing of being unhealed, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.
The specific Aims of this study are to:
Specific Aim 1. Evaluate the effect of treatment of infected fractures that have not yet healed in bone fractures treated with revision fixation and either: (Group 1) operative debridement and PO antibiotic suppression for 6 weeks; or (Group 2) operative debridement and 6 weeks IV antibiotics.
Primary Hypothesis 1a: The rate of re-hospitalization for injury-related complication by one year in Group 1 will be non-inferior to the rate in Group 2.
Hypothesis 1b:. The rate of treatment failure by one year in Group 1 will be non-inferior to the rate in Group 2.
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
- 否
入选标准
- •1. Bone fracture (proximal to and including the tarsal/metatarsal joint (Lisfranc) or proximal to the carpal joints (includes distal radius fractures), excluding pelvis and spine) that has previously undergone fixation and has not healed and requires fixation to be retained or replaced at least until bone union. Fractures that have not healed and require revision fixation are also eligible.
- •Infection as determined by either
- •FRI criteria
- •CDC criteria (without the timeframe) This includes the possibility of culture negative, but determined to be infection by treating surgeon
- •Systemic antibiotic treatment regimen scheduled for at least 6 weeks
排除标准
- •Patients with a high risk of amputation based on the initial managing physician
- •Patients undergoing treatment of any other investigational therapy within the month preceding infection treatment or planned within the 12 months following infection treatment
- •Incarcerated or institutionalized patients
- •Patients who are unable to return for required follow-up visits and/or medical co-morbidities which preclude treatment with a general anesthetic
- •Patients with a prior history of chronic infection at the index site before fracture fixation
- •Patients with pathological fractures from a neoplastic process
- •History of Paget's Disease
- •The patient, or a designated proxy, unwilling to provide consent
- •The patient must be available for follow-up for at least 12 months following infection treatment
研究组 & 干预措施
Standard of Care Intravenous (IV) antibiotics
An intervention in this study includes randomization of patients with an infected unhealed fracture to intravenous (IV) antibiotics for up to 6 weeks post hospitalization. No medications will be provided by the study. Study participants will be prescribed their IV antibiotics by their treating physician and the specific type will depend on their infection diagnosis. Medications will be obtained using health insurance and/or resources available at the treating facility therefore the mode of antibiotics utilized as standard of care will vary across participating sites. Sites will follow their standard of care delivery for antibiotics, and the study will defer to this standard.
干预措施: Standard of Care Intravenous (IV) antibiotics (Drug)
Standard of Care PO (oral) antibiotics
An intervention in this study includes randomization of patients with an infected unhealed fracture to standard of care PO (oral) antibiotics for up to 6 weeks post hospitalization. No medications will be provided by the study. Study participants will be prescribed their oral antibiotics by their treating physician and the specific type will depend on their infection diagnosis. Medications will be obtained using health insurance and/or resources available at the treating facility therefore the mode of antibiotics utilized as standard of care will vary across participating sites. Sites will follow their standard of care delivery for antibiotics, and the study will defer to this standard.
干预措施: Standard of Care PO (oral) antibiotics (Drug)
结局指标
主要结局
Number of patients with a hospital re-admission
时间窗: 1 year
Total number of re-admissions after revision fixation over the first 365 days post discharge from the hospitalization for initial surgical treatment of the infected nonunion. Re-admission can be for infection, nonunion, soft tissue revision, line complication, or antibiotic complication.
次要结局
- Number of patients with treatment failure(1 year)
- Number of patients with a re-hospitalization for a complication(1 year)
- Number of patients with an additional infection(1 year)
- Number of patients that experienced amputation(1 year)
- Medical Costs(1 year)
- Patient Reported Outcomes(1 year)
- Physical and Psychosocial Function Assessment(1 year)
- Adherence(6 months)
- Compliance(6 months)