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临床试验/NCT06096025
NCT06096025进行中(未招募)不适用

Short Versus Long Duration of Therapy for Streptococcus Pneumoniae Bloodstream

Methodist Health System1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年6月23日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
1
主要终点
Recurrence

研究概览

简要总结

Streptococcus pneumoniae is a gram-positive (GP) bacteria responsible for common infections such as community-acquired pneumonia (CAP), as well as complicated infections such as bacteremia, infective endocarditis and meningitis. S. pneumoniae bacteremia ranks among the top 10 most common pathogens associated with bloodstream infections and correlates with high morbidity and mortality worldwide.

详细描述

The Infectious Diseases Society of America (IDSA) guidelines for CAP management advocate for short courses of antibiotics for CAP treatment. However, it does not address duration of therapy for common CAP pathogens such as S. pneumoniae when associated with blood stream infections (BSI). 3

Currently, GP bacteremia duration of therapy typically ranges from 7 to 14 days based on IDSA guideline recommendations for Staphylococcus aureus bacteremia with no further definitive consensus.4 Additionally, lack of data and randomized clinical trials on the efficacy and safety of short compared to long treatment duration have led to variability in practice. Most randomized clinical trials as well as retrospective studies on treatment duration, have been conducted mainly in gram-negative BSI

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • ≥18 years of age
  • S. pneumoniae isolated from ≥1 blood cultures
  • Active IV antibiotic therapy within 48 hours of the first positive blood culture(7,8)
  • Clinical stability by day 10 of therapy

排除标准

  • • Treatment duration <5 days or >16 days
  • Death before completion of therapy (<10 days vs. ≥ 10 days )
  • Polymicrobial BSI
  • Invasive infection caused by S. pneumoniae (endocarditis, meningitis, and lung abscess)

结局指标

主要结局

Recurrence

时间窗: 30 days

Reinfection with streptococcal pneumonia, within 30 days of antibiotic completion

All-cause mortality

时间窗: 30 days

Death within 30 days of antibiotic completion

Infection related-hospitalization

时间窗: 30 days

hospital readmission with streptococcal pneumonia, bacteremia, endocarditis, meningitis, and lung abscess within 30 days of antibiotic completion

次要结局

  • Central venous catheter placement(30 days)
  • ICU Length of stay(LOS)(30 days)
  • Hospital LOS(30 days)
  • Occurrence of C. difficile infection(30 days)
  • Total antibiotic treatment duration(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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