NCT02123628已完成4 期
Six- Versus Twelve-Week Therapy for Non-Surgically-Treated Diabetic Foot Osteomyelitis: A Multicenter Open-Label Controlled Randomized Study
Tourcoing Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary outcome measure was the proportion of patients of each group with remission of diabetic foot osteomyelitis at the end of follow-up.
研究概览
简要总结
The purpose of the study is to compare the efficacy and tolerance of 6- versus 12-week antibiotic therapy in patients with diabetic foot osteomyelitis treated medically.
详细描述
The aim of this randomized multicenter clinical study is to compare the efficacy and tolerance of 6 versus 12-week antibiotic treatment in patients with diabetic foot osteomyelitis treated medically as no equivalent data are currenty available in the literature.
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
- •diabetic patients treated non-surgically (i.e. without amputation or resection of the infected bone) for an osteomyelitis of the foot complicating a neuropathic foot without ischemia of the foot defined as the absence of any pedal pulse. Patients aged of 18 years or more were included if they had type 2 diabetes and osteomyelitis of the foot (i.e.below the ankle).
排除标准
- •Patients with gangrene or who require bone resection or amputation when osteomyelitis of the foot was diagnosed
研究组 & 干预措施
antibiotic therapy
Active Comparator
patients are treated with a 6 week-duration of antibiotic therapy :
- Rifampin IP and PO twice daily, 10mg/kg /12H
- Levofloxacin IV and PO 500-750mg once daily
- Doxycycline PO 200mg once daily
- Trimethoprim- sulfamethoxazole IV and PO 800/160mg thrice daily
- Fusidic acid PO 500mg twice daily
- Linezolid IV and PO 600mg twice daily
- Ciprofloxacin IV and PO 750to 1000mg/12h
- Cefotaxime IV 100mg/kg in three IV infusions daily
- Ceftriaxone IV,intramuscularly or subcutaneously 2g once daily
- Cefepime IV ou intra-muscularly 2g /8-12h
干预措施: duration of the antibiotic therapy (Drug)
12 week-duration of antibiotic therapy
Active Comparator
patients are treated with a 12 week-duration of antibiotic therapy :
- Rifampin IP and PO twice daily, 10mg/kg /12H
- Levofloxacin IV and PO 500-750mg once daily
- Doxycycline PO 200mg once daily
- Trimethoprim- sulfamethoxazole IV and PO 800/160mg thrice daily
- Fusidic acid PO 500mg twice daily
- Linezolid IV and PO 600mg twice daily
- Ciprofloxacin IV and PO 750to 1000mg/12h
- Cefotaxime IV 100mg/kg in three IV infusions daily
- Ceftriaxone IV,intramuscularly or subcutaneously 2g once daily
- Cefepime IV ou intra-muscularly 2g /8-12h
干预措施: duration of the antibiotic therapy (Drug)
结局指标
主要结局
Primary outcome measure was the proportion of patients of each group with remission of diabetic foot osteomyelitis at the end of follow-up.
时间窗: one year
Remission was defined as the absence of any sign of infection at the initial or a contiguous site, evaluated at least one year after the end of antibiotic treatment (ie at the end of follow-up), with neither a new infectious episode nor the need for orthopedic surgery of the foot at either of these sites during the treatment and follow-up period.
次要结局
- tolerance to treatment in each group of patients(6 or 12 weeks)
研究者
研究点 (1)
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