Study of the Impact of a Targeted Decolonization of S. Aureus Persistent Carriers on the Occurrence of S. Aureus Infections in Hemodialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 434
- 试验地点
- 9
- 主要终点
- S. aureus infection
研究概览
简要总结
S. aureus nasal carriage is a well-known risk factor for S. aureus infections in hemodialysis (HD) patients. Strains of carriage and infections are the same in >80% of cases We recently shown that persistent carriers of S. aureus, not intermittent ones are at increased risk of staphylococcal infections in HD. Thanks to a new algorithm developped based on one nasal sample the determination of carriage status (persistent, intermittent or non-carriers) among patients is easy. Mupirocin use in HD have been shown to reduce significantly S. aureus infections however, multiples schedules of decolonization have been proposed to all S. aureus carriers. To date, there is no national guideline for decolonization of S. aureus in HD. We showed that only 50% of HD centers in France propose screening and decolonization of S. aureus carriers. The aim of the study is therefore to evaluate the impact of a targeted decolonization of S. aureus persistent carriers using mupirocin nasal ointment and chlorhexidine baths during 5 days on the occurrence of S. aureus infections in HD patients compared to the absence of decolonization using a randomized open study methodology.
详细描述
Hemodialysis patients will be randomized in 2 arms: one arm where persistent carriers will be decolonized. Decolonization schedule associate the use of mupirocin nasal ointment 3 times a day and chlorhexidine bath once a day for 5 days. Screening of persistent carriers in this arm will be done every 3 months and a new decolonization will be proposed to patients found (again) persistent carriers. Determination of carriage status will be done using one nasal swab by following the algorithm previously described. Bacterial load will be determined by a quantitative S. aureus PCR (Polymerase Chain Reaction) : persistent carriers are the patient with a bacterial load > 103 CFU/mL (Colony Forming Unit) .
The other arm is HD patients in which decolonization is not performed including impersistent carriers.
All infections that occurred in enrolled patients will be counted in both groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (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
- •Adults (age ≥ 18 years-old)
- •Patient under chronic hemodialysis
- •Patent that accepted to participate in the study with a written consent form signed
排除标准
- •Patients under peritoneal dialysis
- •Patients with an active infection at the time of inclusion
- •Patients previously treated by mupirocin and chlorhexidine for decolonization purpose
- •Patients that received antimicrobials active on S. aureus during the month before the inclusion
- •Patients with allergy to mupirocin or chlorhexidine
- •Patients treated by hemodialysis transiently (non-terminal kidney failure)
- •Pregnancy
研究组 & 干预措施
Decolonization
persistent carriers will be decolonized. Decolonization schedule associate the use of mupirocin nasal ointment 3 times a day and chlorhexidine bath once a day for 5 days.
干预措施: Decolonization (Drug)
No decolonization
HD patients in which decolonization is not performed including impersistent carriers.
干预措施: No decolonization (Other)
结局指标
主要结局
S. aureus infection
时间窗: 12 months
Number of S. Aureus define by Centers for Disease Control
次要结局
- strain of S. aureus(12 months)
- other bacterial infections(12 months)
- endogenous S. aureus infections(12 months)
- Bacteremias S. aureus(12 months)
- persistents carriers of S. aureus(Months : 3, 6, 9, 12)
- non-carriers carriers of S. aureus(Months : 3, 6, 9, 12)
- intermittents carriers of S. aureus(Months : 3, 6, 9, 12)