跳至主要内容
临床试验/NCT04153604
NCT04153604已完成不适用

Doxycycline for the Prevention of Spontaneous Bacterial Peritonitis

Methodist Health System1 个研究点 分布在 1 个国家目标入组 841 人开始时间: 2019年11月4日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
841
试验地点
1
主要终点
Occurrence of reported SBP

研究概览

简要总结

The utilization of doxycycline for SBP prophylaxis is a novel practice at MDMC. Therefore, an assessment of safety and efficacy is needed in order to generalize this practice. The publication of this study can potentially introduce a new alternative to guideline-directed therapies for secondary prevention of SBP. Doxycycline is non-inferior to guideline-directed therapies regarding safety and efficacy in primary and secondary prophylaxis for SBP.

详细描述

Spontaneous bacterial peritonitis (SBP) is a common and serious complication in cirrhotic patients with a reported mortality rate of 20 to 30%.1-3 A SBP diagnosis requires abdominal paracentesis and is made in the presence of an elevated ascitic fluid absolute polymorphonuclear leukocyte (PMN) count without an evident intra-abdominal, surgically treatable source of infection.2,3 Common pathogens associated with SBP are Gram-negative colonic organisms. However, in recent years, Gram-positive pathogens have become more common, suggesting the need to evaluate SBP management.1,4-6 The recurrence rate of SBP after an initial episode has been reported to be as high as 70%.1-3 Currently, the American Association for the Study of Liver Disease (AASLD) and European Association for the Study of the Liver (EASL) guidelines recommend the use of sulfamethoxazole/trimethoprim, norfloxacin, or ciprofloxacin for the prevention of recurrent SBP. Fluoroquinolones as a class have had increased black box warnings in recent years, making ciprofloxacin fall out of favor for long-term prophylaxis.5 Sulfamethoxazole/trimethoprim is extensively metabolized by the liver and is contraindicated in marked liver impairment.8 Therefore, it is necessary to search for a prophylaxis alternative with similar efficacy and a better safety profile.

Doxycycline is a broad-spectrum antibiotic that covers Gram-positive bacteria, including Streptococcus spp., resistant strains of Staphylococcus and Enterococcus, and Gram-negative bacteria, including Enterobacteriaceae. One randomized trial in cirrhotic patients with a previous episode of SBP showed that doxycycline was associated with a reduction in inflammatory markers, such as interleukin-6 and C-reactive protein, suggesting potential benefits of doxycycline in this patient population.7 At Methodist Dallas Medical Center (MDMC) and the Liver Institute at MDMC, doxycycline has been utilized for both primary and secondary prevention of SBP. In order to compare doxycycline with guideline-directed therapies for SBP prevention in cirrhotic patients, a retrospective, cohort study was designed to review patients who meet the criteria from July 2014 to July 2018. This study aims to compare the efficacy of doxycycline with that of guideline recommended therapies for primary and secondary SBP prophylaxis, the safety of doxycycline with that of guideline recommended therapies for primary and secondary SBP prophylaxis, and identify the association between chemoprophylaxis and the risk of infections from multidrug resistant organisms (MDROs) in SBP.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Patients ≥ 18 year-old with refractory ascites who are candidates for SBP prophylaxis per clinician's decision
  • Patients diagnosed with cirrhosis based on clinical criteria
  • Patients with a diagnosis of SBP confirmed by paracentesis

排除标准

  • Patients who have secondary peritonitis other than SBP
  • Patients who have a history of liver transplant prior to the initial episode of SBP
  • Patients with incomplete medical records

结局指标

主要结局

Occurrence of reported SBP

时间窗: July 2014 to July 2018

Occurrence of reported SBP within 1-year of chemoprophylaxis initiation

次要结局

  • Hospitalizations and ED visits due to diarrhea(July 2014 to July 2018)
  • Hospitalizations and ED visits due to AKI(July 2014 to July 2018)
  • Hospitalizations and ED visits due to hyperkalemia(July 2014 to July 2018)
  • Incidences of death(July 2014 to July 2018)
  • Incidences of bacteremia(July 2014 to July 2018)
  • Rate of infection with MDRO(July 2014 to July 2018)
  • Incidences of Liver transplant(July 2014 to July 2018)
  • Hospitalizations and ED visits due to Clostridioides difficile infection(July 2014 to July 2018)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Doxycycline for the Prevention of Spontaneous... | 临床试验