ACTRN12619000407190撤回未知
Comparison of the effect of an early transition to oral versus prolonged intravenous antibiotic treatment strategy on clinical outcomes in residual osteomyelitis post surgical debridement in diabetic foot infections: a randomised open-label pilot study
适应症
试验速览
- 阶段
- 未知
- 状态
- 撤回
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Adult inpatients requiring surgical management for diabetic foot infection
- •Positive bone chip (culture or microscopy) post-surgical procedure or negative bone chip (culture or microscopy)with high clinical suspicion for a residual osteomyelitis
- •Type 1 or 2 diabetes mellitus
- •Infection below ankle
- •Likely to be able to be followed at health facility for subsequent six months
- •Has received 7 days or less of intravenous therapy since admission to the hospital
- •Is willing and able to give informed consent
排除标准
- •Patients with toe pressure < 30mmHg despite revascularisation
- •An infection for which (as per ID Physician’s opinion) there are no suitable antibiotic choices to permit randomisation between the two arms of the trial (for example, where organisms are only sensitive to intravenous antibiotics)
- •Systemic sepsis (eg. hypotension requiring inotropic support, blood cultures positive for Staphylococcus aureus) or other indications that mandate prolonged intravenous antibiotics
- •Significant restricted therapeutic options (to either intravenous or oral antibiotics alone) because of patient or microbiological factors (eg. allergy, drug resistance)
- •Pregnant women
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