Prevalence and Predictors of Initial Oral Antibiotic Treatment Failure in Adult Emergency Department Patients With Cellulitis: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 3
- 主要终点
- Treatment failure
研究概览
简要总结
The term cellulitis is a medical term describing a bacterial infection of the skin and tissues beneath the skin. Although it is usually easily treated with antibiotics given either orally or through a vein (intravenously), knowing which route of antibiotic treatment to prescribe to a person attending an Emergency Department with cellulitis is not clear.
A Clinical Prediction rule (CPR) is a decision-making tool that comes from original research as opposed to the opinion of experts. We intend to create a preliminary CPR to decide which patients require oral and which patients require intravenous antibiotics for cellulitis from their first visit to an emergency department. The aim of this is to provide safer care by reducing the risk of a patient returning to the hospital with a worsening infection. It will also promote more cost-effective care by reducing hospital re-attendance rates and wasted antibiotics.
Patients attending the department with cellulitis who are suitable for oral antibiotic treatment will be enrolled into this study. A separate doctor will re-examine at least 10% of study participants in order to reduce bias. A set of physical signs and symptoms will be recorded from each patient in order to determine which ones are associated with them "failing" prescribed oral treatment. A study investigator will then phone the patient after 14 days to see whether they are better or whether they required intravenous antibiotics to get better.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >16 years
- •Suitable for treatment with flucloxacillin 500mg -1gram qds monotherapy or a suitable alternative for penicillin allergic patients as listed in the local prescribing guidelines.
- •Appearance of typical, plaque-like area of erythema over any body part excluding the perineum within the preceding 5 days with any 2 of the following signs:
- •1.Increased warmth over affected area
- •2.Swelling of affected area
- •3.Pain over affected area
- •4.Regional lymphadenopathy
排除标准
- •Requirement for IV antibiotics as decided by the treating clinician.
- •Age less than 16 years.
- •No telephone or access to a telephone.
- •Abscess alone without co-existing signs of cellulitis
- •Mammalian bite wounds.
- •Infected diabetic foot ulcer
- •Necrotising soft tissue infections.
- •Perineal cellulitis.
- •Suspected septic arthritis or osteomyelitis.
- •Decubitus ulcers.
- •Bilateral cellulitis (as this entity rarely exists).
- •Acute lipodermatosclerosis.
- •Acute dermatitis.
- •Venous stasis dermatitis.
- •Deep vein thrombosis.
- •Pregnancy.
- •Cognitive impairment.
- •Any patient who through language barrier or diminished capacity is unable to understand the scope of the study
结局指标
主要结局
Treatment failure
时间窗: 2 weeks post commencement of oral treatment
The primary outcome is the proportion of patients initially commenced on oral antibiotics who subsequently require IV antibiotics to achieve treatment response. This will be assessed by means of telephone follow-up performed at 14 days post enrolment into the study. Treatment failure is defined as attendance at a treating Emergency Department for intravenous antibiotic therapy if already commenced on oral therapy.
次要结局
- Treatment failure - change in type or dose(2 weeks)
- Inter-observer reliability for candidate predictor variables(At enrolment)
- Loss to follow up(2 weeks)