Short 3-week Antibiotic Treatment Versus 6 Weeks in Adults With Septic Arthritis of Native Joint: a Randomized, Open Label, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 332
- 试验地点
- 61
- 主要终点
- Cure at 16 weeks (4 months) after the beginning of the treatment
研究概览
简要总结
In France, the incidence of native joint infections is about 10 per 100 000 person-years, most commonly caused by S.aureus followed by b-haemolytic streptococci. French and international antibiotic guidelines, based on expert advice and retrospective studies, recommend intravenous antibiotics for two weeks, then oral for 4 weeks without evident link between intravenous, prolonged oral treatment and cure. Long term exposure to antibiotics increases bacterial resistance, a major problem of public health. Several studies show that serious infectious can be treated safely by a shorter treatment and with oral antibiotics. There is no randomized controlled trial to establish the duration of antibiotics in native joint infections. Moreover, no consensus prevails on the administration route and duration of antimicrobial therapy. Although most clinicians acknowledge the interest of oral antibiotics and shorter treatment duration, randomized controlled trials are necessary to evaluate this practice. The SHASAR project aims to evaluate whether a shorter antibiotic treatment (3 week treatment) is safe and not inferior to the conventional 6 week treatment in native joint infections. If successful, this would represent a major advance in terms of patients' quality of life; decreased rate of health-care-related infections and complications, bacterial resistance and cost.
详细描述
This trial is a nationwide, non inferiority, multicenter French randomized, open-label, controlled trial comparing two treatment durations, 3 versus 6 weeks, in septic arthritis of native joints. Patients who fulfill inclusion criteria will be randomized between day0 and day5. Day 0 is the time when effective intravenous antibiotic treatment is started. Effective treatment is defined by active antibiotics on the identified bacteria according to the susceptibility. The randomisation (1:1 ratio) will be stratified on early planned drainage. Follow-up will include 6 visits and will consist in clinical, biological, radiological, health quality of life (EQ-5D-3L score) and adverse events record. After collection, validation of data and population description, analysis will be conducted on the per-protocol population (patients receiving the planned duration of antibiotic +/-3days). This study will not be carried out blind for feasibility reasons. According to statistical considerations (by accounting for 5% of subjects lost to follow-up), the required sample size will be of 350 patients overall.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Septic arthritis of native joint defined by: 1) clinical signs (hot and/or swollen and/or tender and painful joint (measured by a visual analogue scale)) and 2) microbiologically confirmed pyogenic arthritis (microorganism cultured in the synovial fluid joint or in the blood with complete bacterial susceptibility)
- •Patients aged of 18 years or older
- •Informed, written consent obtained from the patient
- •Patient having the rights to French social insurance
排除标准
- •Prosthetic joints
- •Septic arthritis in the past 12 months
- •Osteomyelitis
- •Diabetic foot
- •Septic choc
- •Arthritis due to bacteria resistant to available oral antibiotics
- •Arthritis due to the following microorganisms: Mycobacterium, fungi, Brucella, Borrelia, Neisseria gonorrhoeae, Neisseria meningitidis, Nocardia, Mycoplasma spp, Pseudomonas aeruginosa.
- •Glomerular filtration rate < 30ml/min/1,73m2
- •Neutrophils < 500/mm3
- •Difficulties regarding compliance with oral antibiotics
- •Contraindication to oral antibiotics necessary to treat joint infection
- •Pregnancy or lactating woman
- •Curator or guardianship
- •Participation in other interventional research during the study
结局指标
主要结局
Cure at 16 weeks (4 months) after the beginning of the treatment
时间窗: 16 weeks after Day 0
Cure is defined as absence of clinical signs of joint infection, absence of treatment failure, absence of relapse
次要结局
- Cure at 24 weeks(24 weeks after Day 0)
- joint mobility(at 16 and 24 weeks after Day 0)
- Treatment failure and relapse and relapse rates(6,16,24 weeks after Day 0)
- hospital length of stay and total treatments costs(through study completion, an average of 3 years)
- The patient's quality of life(3,6,16,24 weeks after Day 0)
- The residual joint pain in the affected joint(at 16 and 24 weeks after Day 0)