Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Clinical Remission of systemic infection
研究概览
简要总结
The optimal duration of systemic antibiotic administration for native joint septic arthritis is unknown. The investigators perform a randomized study allowing up to 3 surgical lavages and allocating patients into a two-week's and a four week's randomization arm
详细描述
The optimal duration of systemic antibiotic administration for native joint septic arthritis is unknown. The investigators perform a randomized study allocating patients into a two-week's and a four week's randomization arm.
The adult patients are hospitalized for septic arthritis. A computer program randomizes 1:1 between a two week's and a four week's arm of targeted antibiotic treatment of which at least the first week is intravenously. The randomization may occur until Day 5 of admission. Up to three surgical interventions are allowed. The investigators allow the inclusion of all bacterial arthritis and all joints.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >17 years
- •Microbiologically-confirmed septic arthritis
- •At least one surgical drainage/lavage
排除标准
- •Presence of osteosynthesis material in the vicinity of the articulation
- •Presence of a concomitant infection needing more than 2 week's of antibiotic therapy
- •More than 3 surgical drainages
- •Life expectancy less than 6 months
- •Chronic osteomyelitis in vicinity of the arthritis
研究组 & 干预措施
Two week's arm - surgery
The investigators perform a surgical drainage and removal of the infected orthopedic implant.
干预措施: Two week's arm - surgery (Procedure)
Four week's arm - surgery
The investigators surgically remove the infected implant.
干预措施: Four week's arm - surgery (Procedure)
Two week's arm - drugs
The investigators perform a surgical drainage and removal of the infected orthopedic implant. They start an empirical antibiotic treatment based on patient's history and co-morbidities, such as vancomycin or amoxicillin/clavulanic acid. The adapt later on the targeted antibiotic therapy according to the causative pathogens and their antibiotic susceptibility testing.
干预措施: Two week's arm - drugs (Drug)
Four week's arm - drugs
The investigators surgically remove the infected implant and all soft tissue infection. Instead of a total of 2 week's of antibiotic therapy, they administer a total of 4 weeks of systemic antibiotic therapy targeted to the pathogen(s).
干预措施: Four week's arm - drugs (Drug)
结局指标
主要结局
Clinical Remission of systemic infection
时间窗: 6 months
Measurement of fever.
Sequels
时间窗: 6 months
Patient's remaining gait disorders. * range of movement in adjacent joints of former infection * questionnaire regarding persistant pain and handicaps (open wording)
次要结局
- Presence of pus(6 months)
- Wound redness(6 months)
- Wound discharge(6 months)
研究者
Ilker Uckay
Attending, Docent Dr. med Ilker Uçkay
University Hospital, Geneva