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临床试验/NCT07322549
NCT07322549已完成不适用

Amoxicillin/Clavulanic Acid Susceptibility in Acute Community-acquired Pneumonia Documented With Streptococcus Pneumoniae, Haemophilus Influenzae, or Staphylococcus Aureus Requiring Intensive Care Management: a Single-center Retrospective Study.

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
104
试验地点
1
主要终点
Susceptibility rate to AMC and/or 3GC for identified bacteria at CAP or CAAP diagnosis

研究概览

简要总结

Severe community-acquired pneumonia (CAP) and community-acquired aspiration pneumonia (CAAP) are common reasons for adult emergency department visits and subsequent admission to the intensive care unit (ICU). Three bacteria are primarily implicated in this type of pneumonia: Streptococcus pneumoniae, Haemophilus influenzae, and Staphylococcus aureus.

Empirical antibiotic therapy for this condition is currently based on the use of beta-lactams. While third-generation cephalosporins (3GC) remain the beta-lactam of choice in French guidelines for CAP, the combination of Amoxicillin/Clavulanic Acid (AMC) at high-dose (>3g/day) could represent an alternative. AMC is already recommended for severe CAAP and for non-severe CAP in France, and for severe CAP in the UK and the United States. Furthermore, good practice guidelines encourage the use of empirical antibiotic therapies that are then subsequently tailored to the narrowest-spectrum agents based on antibiograms. This approach aims to limit the emergence of multidrug-resistant bacteria and reduce the risk of Clostridioides difficile colitis, which can increase patient morbidity and mortality.

This study aims to evaluate the susceptibility to AMC and 3GC, and to describe the empirical antibiotic therapies used and their subsequent adjustments, in adult patients admitted to the ICU for severe CAP and CAAP documented with Streptococcus pneumoniae, and/or Haemophilus influenzae, and/or Staphylococcus aureus.

详细描述

Observational retrospective monocentric cohort including all the consecutive adult ICU patients admitted from january 2018 to november 2022 with a CAP or a CAAP documented to Streptococcus pneumoniae, and/or Haemophilus influenzae, and/or Staphylococcus aureus.

研究设计

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

入排标准

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

入选标准

  • Patient admitted to the ICU at Sainte-Musse Hospital between January 2018 and December
  • Diagnosis of severe CAP or CAAP within 48 hours of hospital admission, documented with Streptococcus pneumoniae, and/or Haemophilus influenzae, and/or Staphylococcus aureus (confirmed by blood culture and/or a respiratory sample), with an available antibiogram.

排除标准

  • Patient under 18 years old.
  • Patient hospitalized within 3 months prior to hospital admission.
  • Infectious documentation of another pathogen within 48 hours of hospital admission.
  • Nosocomial pneumonia.
  • Patient under legal guardianship (inmate, legal ward, curatorship).

研究组 & 干预措施

Patients with severe community-acquired pneumonia

Pneumonia documented with Streptococcus pneumoniae, and/or Haemophilus influenzae, and/or Staphylococcus aureus

干预措施: Susceptibility to AMC (Other)

Patients with severe community-acquired pneumonia

Pneumonia documented with Streptococcus pneumoniae, and/or Haemophilus influenzae, and/or Staphylococcus aureus

干预措施: Susceptibilty to 3GC (Other)

结局指标

主要结局

Susceptibility rate to AMC and/or 3GC for identified bacteria at CAP or CAAP diagnosis

时间窗: Up to 28 days

The antibiotics of interest are: * The combination of Amoxicillin/Clavulanic Acid (AMC) * Third-generation cephalosporins (3GCs)

次要结局

  • Patient characteristics according to AMC sensitivity(Up to 28 days)
  • Susceptibility rate to empirical recommended beta lactam (AMC, 3GC, and piperacillin/tazobactam)(Up to 28 days)
  • Mortality rate(Up to 28 days)

研究者

发起方
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
申办方类型
Other
责任方
Sponsor

研究点 (1)

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