Oral Beta-lactams Versus Non-beta-lactamS for Treatment of Lower Extremity Osteomyelitis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 1,418
- 试验地点
- 3
- 主要终点
- Primary Effectiveness Outcomes
研究概览
简要总结
The goal of this clinical trial is to compare different classes of oral antibiotics (beta-lactam and non-beta-lactam antibiotics) for the treatment of bone infections of the leg and foot. The hypothesis is that oral beta-lactam antibiotics work as well as oral non-beta-lactam antibiotics to treat these infections. The first step is to assess whether it is possible to perform the trial by determining whether participants can be recruited and followed successfully. If the trial is proven to be possible, it will be expanded to ensure an answer to whether the two antibiotic classes work as well for the treatment of bone infections of the leg and foot.
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
- •Adult (> 18 years old)
- •OM of the lower extremity (below the knee) as determined by the treating healthcare provider (clinically and/or radiographically)
- •Expected duration of treatment at least 28 additional days of antibiotic therapy for the infection episode, from the time of enrolment
- •Treating health care team has already transitioned or is willing to transition to oral antibiotic therapy for the remainder of the treatment duration
排除标准
- •Prior enrolment in the OSTEO trial
- •Already received more than 14 days of uninterrupted antibiotic treatment for this episode of OM
- •No beta-lactam or non-beta-lactam option due to any of:
- •Suspected or confirmed antimicrobial resistance
- •Medical contraindications
- •Non-modifiable drug-drug interaction risk
- •Need to receive combination antibiotic therapy with both beta-lactam and non-beta-lactam, with the exception of metronidazole and rifampin
- •Prior antibiotic treatment for the same infection in the past 6 months
- •Known pregnancy, planning to become pregnant during the study period, or breastfeeding
研究组 & 干预措施
Oral Beta-Lactam Antibiotic
干预措施: Oral Beta-Lactam Antibiotic (Drug)
Oral Non-Beta-Lactam Antibiotic
干预措施: Oral Non-Beta-Lactam Antibiotic (Drug)
结局指标
主要结局
Primary Effectiveness Outcomes
时间窗: 24 Weeks
Cure (defined by meeting the criteria of: alive, not currently receiving antibiotics, no antibiotic switch from the assigned regimen and no surgical amputation)
次要结局
- Secondary Effectiveness Outcomes(24 weeks)
- Secondary Effectiveness Outcome(52 weeks)