NCT07579104

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2025

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

2.9 years

First QC Date

February 10, 2025

Last Update Submit

May 6, 2026

Conditions

Keywords

Klebsiella pneumoniaehypervirulenceliver abscesspyogenicGuadeloupe

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Clinical presentation of pyogenic LA

    Baseline

  • Radiological characteristics of pyogenic liver abscess

    At diagnosis (baseline)

  • Radiological features of pyogenic LA

    Baseline

  • Risk factors associated with Klebsiella pneumoniae pyogenic liver abscess

    Baseline

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

    Baseline

  • +5 more secondary outcomes

Study Arms (1)

Pyogenic liver abscess cohort

All patients diagnosed with pyogenic liver abscess managed at the participating center during the study period.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective cohort of patients with liver abscesses in Guadeloupe

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de La Guadeloupe

Les Abymes, 97159, Guadeloupe

Location

MeSH Terms

Conditions

Liver Abscess, PyogenicLiver Abscess

Condition Hierarchy (Ancestors)

Abdominal AbscessAbscessSuppurationInfectionsLiver DiseasesDigestive System Diseases

Study Officials

  • Sébastien Breurec, MD PhD

    CHU de la Guadeloupe

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2025

First Posted

May 11, 2026

Study Start

March 22, 2021

Primary Completion

February 15, 2024

Study Completion

February 15, 2024

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations