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.

Study Overview

• Status: Completed
• Conditions: Liver Abscess, Pyogenic

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• Guadeloupe
  • Les Abymes, Guadeloupe, 97159
    • CHU de la Guadeloupe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Prospective cohort of patients with liver abscesses in Guadeloupe

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pyogenic liver abscess cohort; All patients diagnosed with pyogenic liver abscess managed at the participating center during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial etiologies associated to pyogenic LA in Guadeloupe	Identification of bacteria responsible for pyogenic liver abscesses through culture (blood and/or pus), with analysis of their antibiotic susceptibility profile.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical presentation of pyogenic LA	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	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	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	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	Analysis of selected virulence genes, antimicrobial resistance genes, and molecular typing (MLST, capsular type).	Baseline
Clinical Cure at 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	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	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	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	Number of participants who die from any cause by Day 30 and Day 90.	Day 30; Day 90

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Guadeloupe
• Investigators: Study Director: Sébastien Breurec, MD PhD, CHU de la Guadeloupe

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Klebsiella pneumoniae; Guadeloupe; liver abscess; pyogenic; hypervirulence
• Additional Relevant MeSH Terms: Infections; Digestive System Diseases; Liver Diseases; Suppuration; Abscess; Abdominal Abscess; Liver Abscess; Liver Abscess, Pyogenic
• Other Study ID Numbers: PAP_RIPH3_2020/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No