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临床试验/NCT06760143
NCT06760143已完成不适用

Antibiotic Prophylaxis in Lung-Transplant Recipients: a Retrospective Cohort Study

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Diagnosis of early postoperative infections and/or bacterial donor-derived infections

研究概览

简要总结

Retrospective, monocentric observational pharmacological cohort study including all adult patients who underwent lung transplantation at IRCCS Azienda Ospedaliero-Universitaria di Bologna from 1st January 2002 to 31st August 2023.

详细描述

Bacterial infections are clinically relevant complications in lung transplant recipients (LTRs) causing chronic lung allograft dysfunction and high rates of mortality, especially within the first year after transplant. Microorganisms responsible for infection can derive from the donor lung or pre-existing recipient flora. Indeed, even though native lungs are removed, colonization of the grafts from recipients colonizing strains often rapidly occurs.

Furthermore, grafts and preservation fluids are frequently infected or colonized with bacteria with a high transmissibility rate to LTRs.

The interpretation of bacterial growth from grafts and preservation fluids can be complex. While some experts recommend against using lungs that show growth of gram-negative bacteria, others permit their use if accompanied by targeted antibiotic therapy, citing retrospective studies that suggest similar overall survival rates for recipients of infected versus uninfected lungs. To prevent donor-derived infections, routine antibiotic prophylaxis is used. International guidelines recommendations are generic and predominantly based on cardiac procedures and no formal recommendations to guide antimicrobial selection in lung transplant (LT) surgery are currently available. Therefore, antibiotic regimens for perioperative prophylaxis are based on clinical judgment and knowledge of the local epidemiology, inducing heterogeneity in clinical practice between centers. In our Center, for the last 20 years, piperacillin/tazobactam plus levofloxacin has been the backbone of the antibiotic prophylaxis regimen for LTRs, according to internal guidelines.

This retrospective observational study aims to investigate the efficacy of piperacillin/tazobactam plus levofloxacin compared to piperacillin/tazobactam alone as antibiotic prophylactic regimens on preventing early bacterial infections and donor derived infection after LT and their possible impact on subsequent colonization by MDR organisms (MDRO). With the study, it will be possible to evaluate which of the two analyzed regimens is associated with a better outcome in the LTR cohort in terms of preventing early surgical site infections, covering the susceptibility of isolates from donor cultures, and influencing MDRO colonization. In this way, it will be possible to influence clinical practice in the center, improving the prognosis of patients undergoing LT. Finally, the data obtained from this study will contribute to increase the knowledge on prophylaxis regimens that can be adopted in hospitals with a similar epidemiological scenario.

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

  • Adult (age ≥ 18 years)
  • Patients who underwent LT at IRCCS Azienda Ospedaliero-Universitaria di Bologna from 1st January 2002 to 31st August 2023
  • Patients receiving peri-operative antibiotic prophylaxis according to internal guidelines at time of LT
  • Signed informed consent

排除标准

  • Lack of clinical and/or laboratory data regarding type of early bacterial infection and/or antibiotic prophylaxis received after lung transplant

结局指标

主要结局

Diagnosis of early postoperative infections and/or bacterial donor-derived infections

时间窗: Retrospective recruitment period will span from January 2001 to August 2023, with a 60-day retrospective follow-up post-transplant

Diagnosis of early postoperative infections and/or donor-derived bacterial infections acquired within 15 days of lung transplantation. This is expressed as a four-group composite endpoint: no infection, early postoperative infections only, donor-derived bacterial infections only, both early postoperative and donor-derived bacterial infections

次要结局

  • Rectal, urinary and/or respiratory colonization rates by MDRO(Retrospective recruitment period will span from January 2001 to August 2023, with a 60-day retrospective follow-up post-transplant)
  • Susceptibility or resistance to piperacillin/tazobactam and/or levofloxacin(Retrospective recruitment period will span from January 2001 to August 2023, with a 60-day retrospective follow-up post-transplant)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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