Duration of Antibiotic Therapy for Cellulitis (DANCE): a Randomized Controlled Trial Comparing 6 to 12 Days of Antibiotic Therapy for Patients Hospitalized With Cellulitis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 151
- 试验地点
- 11
- 主要终点
- Part 1/2: Resolution...
研究概览
简要总结
Cellulitis is among the most common infections leading to hospitalization, yet the optimal duration of therapy remains ill defined. Pragmatically, Dutch guidelines advise 10-14 days of antibiotics, which is the current standard of care. Recently it has been shown that antibiotic treatment for pneumonia and urinary tract infections can safely and significantly be shortened. Importantly, in an outpatient setting, treatment of uncomplicated cellulitis with 5 days of antibiotics was as effective as 10 days. We hypothesize that there is no difference in outcomes when patients hospitalized with cellulitis are treated with either a short-course (6 days) or standard-course (12 days) of antibiotics.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Admitted to receive intravenous antibiotics for cellulitis/erysipelas
- •18 years of age or older
- •Capable of giving written informed consent, able to comply with study requirements and restrictions
排除标准
- •Allergy for flucloxacillin, other beta-lactam antibiotics or one of the additives, or flucloxacillin induced hepatitis or liver enzyme disorders.
- •Concurrent use of antibiotics for other indications
- •Alternative diagnosis accounting for the clinical presentation.
- •All cases involving any of the following complicating factors:
- •Use of antibiotics with Gram-positive activity for more than 4 days in the past 7 days
- •Intensive care unit admission during the last 7 days
- •Severe peripheral arterial disease (Fontaine IV)
- •Severe cellulitis necessitating surgical debridement or fascial biopsy
- •Necrotizing fasciitis
- •Periorbital or perirectal involvement
- •Life expectancy less than one month
- •Risk factors associated with Gram-negative pathogens as a causative agent:
- •Chronic or macerated infra-malleolar ulcers, or infra-malleolar ulcers with previous antibiotic treatment, in patients with diabetes mellitus.
- •Neutropenia
- •Cirrhosis (Child-Pugh class B or C)
- •Intravenous drug use
- •Human or animal bite
- •Skin laceration acquired in fresh or salt open water
- •Fish fin or bone injuries
研究组 & 干预措施
Standard course
Flucloxacillin (1000mg iv OR, later, 500mg capsules), every 6 hours, for 6 days, followed by: Flucloxacillin 500mg capsules, every 6 hours, for 6 days
干预措施: Flucloxacillin (Drug)
Short course
Flucloxacillin (1000mg iv OR, later, 500mg capsules), every 6 hours, for 6 days, followed by: Placebo (for flucloxacillin 500mg) 500mg capsules, every 6 hours, for 6 days
干预措施: Flucloxacillin (Drug)
Short course
Flucloxacillin (1000mg iv OR, later, 500mg capsules), every 6 hours, for 6 days, followed by: Placebo (for flucloxacillin 500mg) 500mg capsules, every 6 hours, for 6 days
干预措施: Placebo (for flucloxacillin) (Drug)
结局指标
主要结局
Part 1/2: Resolution...
时间窗: day 14
Resolution of cellulitis at day 14, defined as disappearance of warmth and tenderness at the site of infection, with substantial improvement in erythema and edema
Part 2/2: ...without relapse
时间窗: day 28
No recurrence by day 28, defined as the need for additional antibiotic therapy for cellulitis
次要结局
- Additional antibiotic usage(Up to 90 days)
- Resolution without relapse(day 28)
- Health care resource utilisation(Up to 90 days)
- Subjective speed of recovery(Up to 90 days)
- Recurrence at day 90(90 days)
- Objective speed of recovery(Up to 90 days)
- Time to relapse(Up to 90 days)
- Health related Quality of Life(Up to 90 days)
研究者
W.J. Wiersinga, MD, PhD
internist, infectious diseases specialist
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)