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Pyogenic Liver Abcess in Guadeloupe (PYG)

6 mei 2026 bijgewerkt door: Centre Hospitalier Universitaire de la Guadeloupe

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

58

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Prospective cohort of patients with liver abscesses in Guadeloupe

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Microbial etiologies associated to pyogenic LA in Guadeloupe
Tijdsspanne: Baseline
Identification of bacteria responsible for pyogenic liver abscesses through culture (blood and/or pus), with analysis of their antibiotic susceptibility profile.
Baseline

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinical presentation of pyogenic LA
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline
Analysis of selected virulence genes, antimicrobial resistance genes, and molecular typing (MLST, capsular type).
Baseline
Clinical Cure at Day 30 and Day 90
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Day 30; Day 90
Number of participants who die from any cause by Day 30 and Day 90.
Day 30; Day 90

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Centre Hospitalier Universitaire de la Guadeloupe

Onderzoekers

  • Studie directeur: Sébastien Breurec, MD PhD, CHU de la Guadeloupe

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

22 maart 2021

Primaire voltooiing (Werkelijk)

15 februari 2024

Studie voltooiing (Werkelijk)

15 februari 2024

Studieregistratiedata

Eerst ingediend

10 februari 2025

Eerst ingediend dat voldeed aan de QC-criteria

6 mei 2026

Eerst geplaatst (Werkelijk)

11 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

6 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PAP_RIPH3_2020/19

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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