Liver Abscess, PyogenicPYGNCT07579104
Pyogenic Liver Abcess in Guadeloupe
An observational study of Liver Abscess, Pyogenic, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Abscess, Pyogenic
- How many people
- 58 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 22 Mar 2021to 15 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective cohort of patients with liver abscesses in Guadeloupe
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Liver Abscess, Pyogenic
- Keywords
- Klebsiella pneumoniae, hypervirulence, liver abscess, pyogenic, Guadeloupe
- Medical subject headings
- Liver Abscess, Pyogenic, Liver Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pyogenic liver abscess cohort | All patients diagnosed with pyogenic liver abscess managed at the participating center during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (10)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 30; Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start22 Mar 2021
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Abscess, PyogenicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien Breurec, MD PhD, Study director, CHU de la Guadeloupe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579104
- Sponsor's protocol ID
- PAP_RIPH3_2020/19
- Acronym
- PYG
- Status last verified
- May 2026
- First submitted
- 10 Feb 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pyogenic Liver Abcess in Guadeloupe
- ClinicalTrials.gov ID
- NCT07579104
- Acronym / sponsor ID
- PYG / PAP_RIPH3_2020/19
- Conditions
- Liver Abscess, Pyogenic
- Keywords
- Klebsiella pneumoniae, hypervirulence, liver abscess, pyogenic, Guadeloupe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyogenic liver abscess cohort | – | –All patients diagnosed with pyogenic liver abscess managed at the participating center during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective cohort of patients with liver abscesses in Guadeloupe
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
10 secondary outcomes
Clinical presentation of pyogenic LA
Time frame: Baseline
Radiological characteristics of pyogenic liver abscess
Time frame: At diagnosis (baseline)
Radiological features of pyogenic LA
Time frame: Baseline
Risk factors associated with Klebsiella pneumoniae pyogenic liver abscess
Time frame: Baseline
Virulence genes, antimicrobial resistance genes, and molecular typing of Klebsiella pneumoniae isolates
Time frame: Baseline
Clinical Cure at Day 30 and Day 90
Time frame: Day 30 and Day 90
Persistent Infection at Day 30 and Day 90
Time frame: Day 30; Day 90
Recurrence of Infection by Day 90
Time frame: Up to Day 90
Infection-Related Complications by Day 30 and Day 90
Time frame: Day 30; Day 90
All-Cause Mortality at Day 30 and Day 90
Time frame: Day 30; Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien Breurec, MD PhD study director
CHU de la Guadeloupe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Abscess, Pyogenic, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial etiologies associated to pyogenic LA in Guadeloupe (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.