Comparison of Two Antimicrobial Therapy Duration (6 Weeks Versus 12 Weeks)for Spondylodiscitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 1
- 主要终点
- Percentage of success in 1 year defined by the absence of infection : absence of clinical, biological and radiological signs of infection (pain, fever) ; or relapse with the same germ.
研究概览
简要总结
Duration of antimicrobial therapy for spondylodiscitis is not standardized; it could vary from 6 weeks to several months depending on the medical habits. The study hypothesis is that a 6 weeks antimicrobial therapy is not inferior to a 12 weeks.
We run a prospective multi-centric, non inferiority open label trial, randomised in two parallel groups.
The main objective is to compare the efficacy of two durations of antibiotherapy, 6 weeks versus 12 weeks, on the rate of cure in this indication.
The study concerns 400 patients more than 18 years, 70 centres in France are involved.
The duration of the study is 4 years.
详细描述
In France, incidence of spondylodiscitis is between 1000 and 1500 new cases a year. Micro-organisms mainly in cause are: Staphylococcus aureus, negative coagulase Staphylococcus, Gram negative bacilli and Streptococci; more rarely mycobacteria or Brucella. Actually, optimal duration of antimicrobial therapy is unclear. The rate of cure varies, according to studies, from 90 to 100 % whatever the responsible germ involved. If a 6 weeks antimicrobial therapy duration is not inferior to 12, this would allow to shortening usual antimicrobial therapy duration, and improve tolerance of the treatment, with ecological and economic benefits, following a politics of good use of antibiotics, defined in the French circular n°2002-272 of 02/05/02.
The main objective is to compare two durations of antimicrobial therapy, 6 weeks versus 12 weeks, on the rate of cure of the bacterial spondylodiscitis. Secondary objectives are to compare, according to the duration of treatment antibiotic, 1) Rachidial pain by clinical examination and an analogical visual scale (EVA), 2) Quality of life by the score EQ-5D, 3) Treatment tolerance. 4) Risk factors for failure.
Type of the study is Prospective multi-centric, open label trial, randomised in two parallel groups with direct individual profit.
Antimicrobial therapy is chosen by the physician on charge of the patient according to the germ and to the consensual recommendations.
The study concerns 400 patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men or women more than 18 years
- •proved bacterial spondylodiscitis due to pyogenic germ (no mycobacteria, no fungus or brucella), for which is decided a treatment antibiotic
- •diagnosis is based on clinical,radiological and microbiological criteria
- •women in age to procreate, use of an effective contraception with protected sexual relations and negative pregnancy test (b HCG).
排除标准
- •infection with no bacteriological identification
- •infection due to mycobacteria, brucella or fungus
- •presence of material
- •recurrence of spondylodiscitis
- •Patient whose life expectation is 1-year-old subordinate
- •pregnant or breast-feeding Woman
研究组 & 干预措施
1
- group A : during 6 weeks after the inclusion
干预措施: antibiotic (Drug)
2
-group B : during 12 weeks after the inclusion
干预措施: antibiotic (Drug)
结局指标
主要结局
Percentage of success in 1 year defined by the absence of infection : absence of clinical, biological and radiological signs of infection (pain, fever) ; or relapse with the same germ.
时间窗: 1 year after the stop of the treatment.
次要结局
- 1)Effective antibiotherapy duration(12 months)
- 2) Failure rate at 6 month(6 months)
- 3)Rachidial pains (clinical examination and analogical visual scale of the pain) at every visit(6 an 12 month)
- 4)Quality of life by the score EQ-5D at 6 and 12 month(6 and 12 month)
- 5)Observance of the treatment measured at every visit(6 and 12 month)
- 6)Appearance of microbial resistances estimated by comparison of antibiogram in case of failure(during 12 months)
- 7)Antimicrobial therapy tolerance measure at each visit(6 and 12 month)
- 8)Identification of risk factors for failure(during 12 months)