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Completed

NCT Number: NCT07579104

Pyogenic Liver Abcess in 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.

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Key information

Conditions

Liver Abscess, Pyogenic Abdominal Abscess Abscess Digestive System Diseases Infections Liver Abscess Liver Diseases Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de La Guadeloupe

Les Abymes, 97159, Guadeloupe

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Microbial etiologies associated to pyogenic LA in Guadeloupe

    Time frame: Baseline

    Identification of bacteria responsible for pyogenic liver abscesses through culture (blood and/or pus), with analysis of their antibiotic susceptibility profile.

Secondary outcomes

  1. Clinical presentation of pyogenic LA

    Time frame: Baseline

    Clinical characteristics at admission, including symptoms (fever, abdominal pain, jaundice), severity of illness (sepsis, septic shock, ICU admission), and associated comorbidities.

  2. Radiological characteristics of pyogenic liver abscess

    Time frame: 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).

  3. Radiological features of pyogenic LA

    Time frame: 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.

  4. Risk factors associated with Klebsiella pneumoniae pyogenic liver abscess

    Time frame: Baseline

    Identification of demographic, clinical, and biological factors associated with K. pneumoniae infection compared with other etiologies, using univariate and multivariate statistical analysis.

  5. Virulence genes, antimicrobial resistance genes, and molecular typing of Klebsiella pneumoniae isolates

    Time frame: Baseline

    Analysis of selected virulence genes, antimicrobial resistance genes, and molecular typing (MLST, capsular type).

  6. Clinical Cure at Day 30 and Day 90

    Time frame: 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.

  7. Persistent Infection at Day 30 and Day 90

    Time frame: 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.

  8. Recurrence of Infection by Day 90

    Time frame: Up to Day 90

    Number of participants with recurrence of infection after initial clinical improvement or cure, occurring within 90 days.

  9. Infection-Related Complications by Day 30 and Day 90

    Time frame: 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.

  10. All-Cause Mortality at Day 30 and Day 90

    Time frame: Day 30; Day 90

    Number of participants who die from any cause by Day 30 and Day 90.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Guadeloupe

Other

Registry information

Acronym: PYG

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 11, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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