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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.

Aperçu de l'étude

Statut

Complété

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

58

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Prospective cohort of patients with liver abscesses in Guadeloupe

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Microbial etiologies associated to pyogenic LA in Guadeloupe
Délai: Baseline
Identification of bacteria responsible for pyogenic liver abscesses through culture (blood and/or pus), with analysis of their antibiotic susceptibility profile.
Baseline

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Clinical presentation of pyogenic LA
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline
Analysis of selected virulence genes, antimicrobial resistance genes, and molecular typing (MLST, capsular type).
Baseline
Clinical Cure at Day 30 and Day 90
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Day 30; Day 90
Number of participants who die from any cause by Day 30 and Day 90.
Day 30; Day 90

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Directeur d'études: Sébastien Breurec, MD PhD, CHU de la Guadeloupe

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 mars 2021

Achèvement primaire (Réel)

15 février 2024

Achèvement de l'étude (Réel)

15 février 2024

Dates d'inscription aux études

Première soumission

10 février 2025

Première soumission répondant aux critères de contrôle qualité

6 mai 2026

Première publication (Réel)

11 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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