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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Les Abymes、グアドループ、97159
- CHU de la Guadeloupe
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
Pyogenic liver abscess cohort
All patients diagnosed with pyogenic liver abscess managed at the participating center during the study period.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Microbial etiologies associated to pyogenic LA in Guadeloupe
時間枠：Baseline
|
Identification of bacteria responsible for pyogenic liver abscesses through culture (blood and/or pus), with analysis of their antibiotic susceptibility profile.
|
Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical presentation of pyogenic LA
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline
|
Analysis of selected virulence genes, antimicrobial resistance genes, and molecular typing (MLST, capsular type).
|
Baseline
|
|
Clinical Cure at Day 30 and Day 90
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Day 30; Day 90
|
Number of participants who die from any cause by Day 30 and Day 90.
|
Day 30; Day 90
|
協力者と研究者
捜査官
- スタディディレクター：Sébastien Breurec, MD PhD、CHU de la Guadeloupe
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。