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Pyogenic Liver Abcess in Guadeloupe (PYG)

Liver abscesses are infections of the liver parenchyma, most often bacterial, occurring via the biliary tract, bloodstream, or by direct spread. Although rare, they are serious, with a mortality rate of around 15%. In Western countries, they are mainly polymicrobial or associated with Escherichia coli, streptococci, and Klebsiella pneumoniae. While overall incidence is low, it appears higher in Guadeloupe.

There is a growing increase in cases caused by hypervirulent *Klebsiella pneumoniae* (hvKp), which can infect healthy individuals and spread to distant sites such as the eye, lungs, and central nervous system. Its virulence is linked to specific genetic factors. The emergence of multidrug-resistant hypervirulent strains represents a major concern. In Guadeloupe, about ten cases per year are reported, with no clearly identified risk factors.

研究概览

地位

完全的

详细说明

Microbial contamination of the liver parenchyma leading to liver abscess (LA) can occur via the bile ducts or vessels (arterial or portal), or directly by contiguity. Infection is usually bacterial, sometimes parasitic, and very rarely fungal. In the Western world, bacterial (pyogenic) LA is the most prevalent; mortality remains high, approaching 15%, mainly due to patient debilitation and persistence of the underlying cause.

Bacterial LA are mainly of polymicrobial origin (35% of cases) or associated with Escherichia coli (39% of cases); other etiologies include streptococci (36.5%) and Klebsiella pneumoniae (9.5%) in France.

The incidence of LA is low, ranging from 8 to 22 cases per 1,000,000 individuals. In Guadeloupe, few data are available; however, the number of cases observed at the Centre University Hospital of Guadeloupe (CHUG) is approximately 30 to 40 per year, suggesting that Guadeloupe is an area of relatively high incidence.

Currently, the incidence of LA associated with hypervirulent Klebsiella pneumoniae (hvKp) is increasing. hvKp is more virulent than classical K. pneumoniae (cKp) and causes community-acquired infections, often in otherwise healthy individuals. In addition to liver abscesses, hvKp is distinguished from cKp by its ability to metastasize to distant sites, most commonly the eye, lungs, and central nervous system.

The genetic determinants of hypervirulence are often located on large virulence plasmids as well as chromosomal mobile genetic elements, which can be used as biomarkers to distinguish hvKp from cKp clinical isolates. These virulence determinants include multiple siderophore systems for iron acquisition, increased capsule production, K1 and K2 capsular types, and the colibactin toxin.

Alarmingly, multidrug-resistant hypervirulent strains have emerged, creating a new challenge in managing this already dangerous pathogen. In Guadeloupe, approximately ten cases of LA associated with hvKp are reported at the CHUG each year, and most patients report no contact with Asia or individuals of Asian origin. Risk factors remain poorly understood.

研究类型

观察性的

注册 (实际的)

58

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Les Abymes、瓜德罗普岛、97159
        • CHU de la Guadeloupe

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Prospective cohort of patients with liver abscesses in Guadeloupe

描述

Inclusion Criteria:

  • Patients of 18 years old and older
  • Radiological diagnosis of hepatic abscess
  • Patients (a close relative if the patient is out of state to give his agreement )who have agreed to participate to the study

Exclusion Criteria:

  • Patients under 18 years old
  • Patient (a close relative if the patient is out of state to give his agreement ) who refuse to participate to the study

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Pyogenic liver abscess cohort
All patients diagnosed with pyogenic liver abscess managed at the participating center during the study period.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Microbial etiologies associated to pyogenic LA in Guadeloupe
大体时间:Baseline
Identification of bacteria responsible for pyogenic liver abscesses through culture (blood and/or pus), with analysis of their antibiotic susceptibility profile.
Baseline

次要结果测量

结果测量
措施说明
大体时间
Clinical presentation of pyogenic LA
大体时间:Baseline
Clinical characteristics at admission, including symptoms (fever, abdominal pain, jaundice), severity of illness (sepsis, septic shock, ICU admission), and associated comorbidities.
Baseline
Radiological characteristics of pyogenic liver abscess
大体时间:At diagnosis (baseline)
Imaging features assessed by CT scan or ultrasound, including abscess size (largest diameter in mm), number of lesions (single vs multiple), hepatic location (lobe/segment), and morphological features (e.g., multiloculation, gas presence).
At diagnosis (baseline)
Radiological features of pyogenic LA
大体时间:Baseline
Radiological characteristics assessed at diagnosis, including abscess size (largest diameter in mm), number of lesions (single vs multiple), location (hepatic lobe and segment), and morphological features (e.g., multiloculation, presence of gas, wall thickness) as evaluated by CT scan or ultrasound.
Baseline
Risk factors associated with Klebsiella pneumoniae pyogenic liver abscess
大体时间:Baseline
Identification of demographic, clinical, and biological factors associated with K. pneumoniae infection compared with other etiologies, using univariate and multivariate statistical analysis.
Baseline
Virulence genes, antimicrobial resistance genes, and molecular typing of Klebsiella pneumoniae isolates
大体时间:Baseline
Analysis of selected virulence genes, antimicrobial resistance genes, and molecular typing (MLST, capsular type).
Baseline
Clinical Cure at Day 30 and Day 90
大体时间:Day 30 and Day 90
Number of participants with complete clinical resolution of infection (absence of signs and symptoms related to the initial infection) at Day 30 and Day 90.
Day 30 and Day 90
Persistent Infection at Day 30 and Day 90
大体时间:Day 30; Day 90
Number of participants with persistence of infection, defined as ongoing clinical signs and/or microbiological evidence of infection at Day 30 and Day 90.
Day 30; Day 90
Recurrence of Infection by Day 90
大体时间:Up to Day 90
Number of participants with recurrence of infection after initial clinical improvement or cure, occurring within 90 days.
Up to Day 90
Infection-Related Complications by Day 30 and Day 90
大体时间:Day 30; Day 90
Number of participants experiencing complications related to the infection (e.g., abscess, sepsis, need for additional intervention) at Day 30 and Day 90.
Day 30; Day 90
All-Cause Mortality at Day 30 and Day 90
大体时间:Day 30; Day 90
Number of participants who die from any cause by Day 30 and Day 90.
Day 30; Day 90

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Sébastien Breurec, MD PhD、CHU de la Guadeloupe

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年3月22日

初级完成 (实际的)

2024年2月15日

研究完成 (实际的)

2024年2月15日

研究注册日期

首次提交

2025年2月10日

首先提交符合 QC 标准的

2026年5月6日

首次发布 (实际的)

2026年5月11日

研究记录更新

最后更新发布 (实际的)

2026年5月11日

上次提交的符合 QC 标准的更新

2026年5月6日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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