Randomized Controlled Clinical Trial Comparing Treatment with Cloxacillin Versus Benzylpenicillin in Bacteraemia Caused by Penicillin-susceptible Staphylococcus Aureus (PSSA)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Survival at 90 days without any treatment complications
研究概览
简要总结
The goal of this study is to investigate if benzylpenicillin is a better treatment option than cloxacillin in patients with penicillin-susceptible Staphylococcus aureus bacteraemia.
详细描述
The overall research idea of is a RCT is to test the hypothesis that benzylpenicillin is superior to cloxacillin in the treatment of PSSA bacteraemia.
Population: Adult patients (>18 years) with PSSA bacteraemia will be eligible for enrolment in the study. Exclusion criteria are allergy to penicillin, inability to give informed consent, and concomitant growth of other clinically significant bacteria in blood cultures. We are planning a nation-wide study.
Intervention: Benzylpenicillin treatment of PSSA bacteraemia will be evaluated. As soon as S. aureus has been identified in blood cultures and the susceptibility testing indicates penicillin susceptibility (Two-three days from start of treatment), patients will be randomized to continue therapy with either cloxacillin or benzylpenicillin. The duration of treatment depends on the type of infection, and details about length of therapy and dosage will be decided by the specific patient diagnosis (i.e., endocarditis, arthritis). Repeated blood cultures and echocardiography are important in the diagnostic work-up of S. aureus bacteraemia and will be included in the study protocol. Patients will also be monitored regarding adverse events, such as liver and renal impairment, rash, diarrhoea, thrombophlebitis et c., and treatment failure, relapse, and mortality.
Control: The study drug (benzylpenicillin) will be compared to cloxacillin, which is the current drug of choice for methicillin susceptible S. aureus in Sweden. Both drugs will be used at clinically recommended doses, with appropriate adjustments for renal impairment if needed. Outcome: Primary outcome is; to be alive for 90 days without any complications. Complications are defined as having any of relapse (90 days after antibiotic finished), need of change or addition of antibiotics due to side effects or treatment failure or adverse events.
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
盲法说明
Study personal assessing the side effects, are as fara as possible unaware of what study drug is given.
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
- •Aged ≥18 with penicillin susceptible S. aureus bacteraemia (PSSA), and able to provide written informed consent.
排除标准
- •allergy to penicillin,
- •inability to give informed consent,
- •concomitant growth of other clinically significant bacteria in blood cultures
- •neutropenia
- •≥ 96h with prior antibiotics
- •When the per oral follow up medication can not be flukloxacillin or penicillinV/Amoxicillin (ie prosthetic joint infection)
- •Patients in terminal palliation, where death is expected within 7 days.
- •Where the treating physician believes cloxacillin is not a first-line treatment.
研究组 & 干预措施
Benzylpenicillin treatment
干预措施: Penicillin G_1200mg (Drug)
cloxacillin
干预措施: cloxacillin (Drug)
结局指标
主要结局
Survival at 90 days without any treatment complications
时间窗: From enrollment to 90 days after end of treatment
Complications are defined as having any of; relapse within 90 days after treatment finish, need of change or addition of antibiotics due to side effects or treatment failure or adverse events.
次要结局
- Mortality at 90 days(From enrollment to 90 days after end of treatment)
- Relapse 90 days after end of treatment(From enrollment to 90 days after end of treatment)
- Cumulative frequency of side effects within 90 days(From enrollment until 90 days.)
- Cumulative frequence of change or addition of antibiotic treatment due to sideeffects or treatment failure(from enrollment to end of treatment duration up to 90 days)
- Decrease of Bacterial DNA in blood samples(From enrollment and first 5 days)
研究者
Malin Hagstrand Aldman
PI, MD, PhD
Region Skane