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Genomic and Phenotypic Diversity of Carbapenemase-producing Escherichia Coli Strains Circulating in Southern France (CARBACOLI)

6. července 2026 aktualizováno: Centre Hospitalier Universitaire de Nīmes

Genomic and Phenotypic Diversity of Carbapenemase-producing Escherichia Coli Strains Circulating in Southern France. The "CARBA-COLI" Study

Carbapenemase-producing Enterobacteriaceae (CPE) are classified as emerging Highly Resistant Bacteria (eHRB) because they expose infected patients to the risk of treatment failure due to the strains' resistance to last-line β-lactams, carbapenems, and frequent co-resistance to other classes of antibiotics, leading to increased morbidity and mortality. Their high epidemiogenic potential has enabled their global spread. In France, the incidence of Carbapenemase-producing Enterobacteriaceae is rising sharply, both in colonization and in infections. Parallel to this increase, Escherichia coli has become the most common Carbapenemase-producing Enterobacteriaceae (35% of strains in 2024, National Research Committee data), surpassing Klebsiella pneumoniae (24%).

The investigators hypothesize that the increase in the prevalence of carbapenemase-producing Echerichia coli is associated with a diversification of clones, enzymes, and their variants, and may pose a threefold threat: i) the spread of genes encoding carbapenemases within pathogenic extraintestinal Echerichia coli (ExPEC) pathogroups responsible for urinary tract infections and bacteremias, with a high risk of resistance spreading in the community, ii) the silent spread of Echerichia coli strains producing OXA-48 variants with reduced carbapenem hydrolytic activity, OXA-244 and OXA-484, which are not detected or poorly detected by conventionally used screening media and iii) the emergence of New Dehli Metallo-beta-lactamase (NDM) variants with high hydrolytic activity, such as NDM-5, within Echerichia coli clones possessing Penicillin-Binding Proteins (PLPs) with low affinity for antibiotics, leading to very high-level resistance and a therapeutic dead end in infected patients.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

Predicted to become the leading cause of death worldwide by 2050, antibiotic resistance poses a major global challenge. In France, the "2022-2025 National Strategy" led by the Ministry of Solidarity and Health combines the promotion of appropriate antibiotic use with preventive measures to control infections involving multi- and highly resistant bacteria, both in the community and in healthcare facilities.

Carbapenemase-producing Enterobacteriaceae (CPE) are classified as emerging Highly Resistant Bacteria (eHRB) because they expose infected patients to the risk of treatment failure due to the strains' resistance to last-line β-lactams, carbapenems, and frequent co-resistance to other classes of antibiotics, leading to increased morbidity and mortality. Their high epidemiogenic potential has enabled their global spread. In France, the incidence of Carbapenemase-producing Enterobacteriaceae is rising sharply, both in colonization and in infections. Parallel to this increase, Escherichia coli has become the most common Carbapenemase-producing Enterobacteriaceae species (35% of strains in 2024 National Research Committee data), surpassing Klebsiella pneumoniae (24%).

In 2011, the Microbiology and Hospital Hygiene Laboratory at Nîmes University Hospital was designated an expert center for emerging Highly Resistant Bacteria, and then, in 2021, a Reference Medical Biology Laboratory for emerging Highly Resistant Bacteria. Between 2023 and 2024, a total of 479 CPE strains were isolated or sent to the laboratory for analysis, representing a 45% increase compared to the 2021-2022 period. Of these strains, 163 were Echerichia coli (vs. 71 between 2021 and 2022, +130%). Furthermore, the number of carbapenemase-producing Echerichia coli strains from diagnostic samples increased very sharply (+231%) during the 2023-2024 period (n=86), compared to 2021-2022 (n=26). These samples came from hospital laboratories and private clinics, as well as community laboratories. The potential for community spread of highly antibiotic-resistant and virulent strains raises concerns about an epidemic outbreak following the same pattern as that of CTX-M extended-spectrum beta-lactamase (ESBL)-producing Echerichia coli in the 2000s. Screening for CPE colonization and adherence to strict additional hygiene precautions in cases of carriage are the means of combating cross-transmission of these strains in healthcare facilities. These preventive measures are not applicable in the community setting.

The investigators hypothesize that the increase in the prevalence of carbapenemase-producing Echerichia coli is associated with a diversification of clones, enzymes, and their variants, and may pose a threefold threat: i) the spread of genes encoding carbapenemases within pathogenic extraintestinal Echerichia coli (ExPEC) pathogroups responsible for urinary tract infections and bacteremias, with a high risk of resistance spreading in the community, ii) the silent spread of Echerichia coli strains producing OXA-48 variants with reduced carbapenem hydrolytic activity, OXA-244 and OXA-484, which are not detected or poorly detected by conventionally used screening media and iii) the emergence of New Dehli Metallo-beta-lactamase (NDM) variants with high hydrolytic activity, such as NDM-5, within Echerichia coli clones possessing Penicillin-Binding Proteins (PLPs) with low affinity for antibiotics, leading to very high-level resistance and a therapeutic dead end in infected patients.

Typ studie

Pozorovací

Zápis (Odhadovaný)

163

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Anissa MEGZARI
  • Telefonní číslo: 0466684236
  • E-mail: drc@chu-nimes.fr

Studijní záloha kontaktů

Studijní místa

    • Gard
      • Nîmes, Gard, Francie, 30029
        • Nîmes University Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

This translational research study involves the analysis of samples from an existing multicenter cohort: the strain bank of the Reference Laboratory for Medical Biology (LBMR) for Emerging Highly Resistant Bacteria (eHRB).

It is a collection of 163 carbapenemase-producing E. coli strains collected at the Microbiology Laboratory between 2023 and 2024.

The panel of E. coli strains isolated from various infections and colonization sites will be selected following genomic characterization to ensure it is as representative as possible of the predominant clones identified. The selected strains will then be phenotypically characterized through further analyses.

Popis

Inclusion Criteria:

  • Not applicable to this study of an existing collection of Carbapenemase-producing Enterobacteriaceae strains.

Exclusion Criteria:

  • Not applicable to this study of an existing collection of Carbapenemase-producing Enterobacteriaceae strains.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Genetic diversity of carbapenemase-producing E. coli strains from the Reference Laboratory for Medical Biology for Emerging Highly Resistant Bacteria
Časové okno: 2 years
Typing via whole-genome sequencing of bacterial genomes and analysis using whole-genome MultiLocus Sequence Typing (wgMLST) to characterize the molecular epidemiology and identify high-risk clones circulating in southern France
2 years
Assessment of the content of antibiotic resistance genes (resistome), virulence genes (virulome), and plasmids (percentage of presence).
Časové okno: 2 years
Resistome, virulome and plasmids will be measured as percentages in each strain identified.
2 years

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Antibiotic resistance phenotype:
Časové okno: 2 years
Antibiotic susceptibility testing on Mueller-Hinton agar plates with determination of Minimum Inhibitory Concentrations (MICs) of last-line antibiotics in liquid Mueller-Hinton medium
2 years
Study of bacterial growth curves for the main identified clones
Časové okno: 2 years
Growth curves will be compared using the Gompertz nonlinear regression model with GraphPad Prism 9.2 software (San Diego, CA, USA).
2 years
Study of biofilm formation (Bioflux 200TM system) for the main identified clones,
Časové okno: 2 years
The Bioflux 200TM system will be used to study biofilm formation
2 years
Study of bacterial motility (swimming, swarming) for the main identified clones
Časové okno: 2 years
The motility of the different bacterial strains will be assessed by comparing the average migration diameters for swimming and swarming. The experiments will be conducted independently three times.
2 years
Performance of eHRB screening media on carbapenemase-producing E. coli strains
Časové okno: 2 years
Performance of the chromID® CARBA-SMART (bioMérieux), the BrillianceTM CRE (Thermo Fisher), and mSuperCARBATM (CHROMagar) will be evaluated and compared following inoculation with a bacterial suspension of various E. coli strains.
2 years
Risk factors for infections caused by carbapenemase-producing E. coli. : Age
Časové okno: 2 years
Age will be recorded in years with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
2 years
Risk factors for infections caused by carbapenemase-producing E. coli. : Sex
Časové okno: 2 years
The patient's sex will be recorded as M/F/non-binary with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
2 years
Risk factors for infections caused by carbapenemase-producing E. coli. : Department of residence
Časové okno: 2 years
The patient's department of residence will be recorded with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
2 years
Risk factors for infections caused by carbapenemase-producing E. coli. : Medical history
Časové okno: 2 years
The patient's medical history will be examined with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
2 years
Risk factors for infections caused by carbapenemase-producing E. coli. : Type of infection
Časové okno: 2 years
The type of infection will be recorded with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
2 years
Risk factors for infections caused by carbapenemase-producing E. coli. : Comorbidities
Časové okno: 2 years
Comorbidities will be recorded with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
2 years
Risk factors for infections caused by carbapenemase-producing E. coli. : Length of hospital stay
Časové okno: 2 years
The length of hospital stay will be recorded in days with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
2 years
Risk factors for infections caused by carbapenemase-producing E. coli. : Invasive devices
Časové okno: 2 years
The presence of invasive devices will be recorded with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
2 years
Risk factors for infections caused by carbapenemase-producing E. coli. : Surgery
Časové okno: 2 years
The need for surgery will be recorded with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
2 years
Risk factors for infections caused by carbapenemase-producing E. coli. : Antibiotic exposure
Časové okno: 2 years
Antibiotic exposure will be recorded with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
2 years
Risk factors for infections caused by carbapenemase-producing E. coli. : Repeat hospitalizations
Časové okno: 2 years
Repeat hospitalizations will be recorded with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
2 years
Risk factors for infections caused by carbapenemase-producing E. coli. : Recent travel
Časové okno: 2 years
Recent travel will be recorded with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
2 years
Risk factors for infections caused by carbapenemase-producing E. coli. : Inter-hospital transfers
Časové okno: 2 years
Inter-hospital transfers will be recorded with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
2 years
Risk factors for infections caused by carbapenemase-producing E. coli. : Cross-transmission
Časové okno: 2 years
Cross-transmission (patient contact) between asymptomatic carriers and individuals with an infection will be recorded with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
2 years

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. srpna 2026

Primární dokončení (Odhadovaný)

1. října 2027

Dokončení studie (Odhadovaný)

1. srpna 2028

Termíny zápisu do studia

První předloženo

24. června 2026

První předloženo, které splnilo kritéria kontroly kvality

24. června 2026

První zveřejněno (Aktuální)

30. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • NIMAO/2025-2/AP-01

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Popis plánu IPD

Data management is handled by BESPIM (Biostatistics, Epidemiology, Public Health & Methodological Innovations, Nîmes University Hospital). The terms and conditions for the transfer of all or part of the research database are determined by the research sponsor and are set forth in a written contract.

Informace o lécích a zařízeních, studijní dokumenty

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Studuje produkt zařízení regulovaný americkým úřadem FDA

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