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Genomic and Phenotypic Diversity of Carbapenemase-producing Escherichia Coli Strains Circulating in Southern France (CARBACOLI)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Anissa MEGZARI
- Telefoonnummer: 0466684236
- E-mail: drc@chu-nimes.fr
Studie Contact Back-up
- Naam: Alix PANTEL, Dr.
- Telefoonnummer: +334.66.68.32.02
- E-mail: alix.pantel@chu-nimes.fr
Studie Locaties
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Gard
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Nîmes, Gard, Frankrijk, 30029
- Nîmes University Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Genetic diversity of carbapenemase-producing E. coli strains from the Reference Laboratory for Medical Biology for Emerging Highly Resistant Bacteria
Tijdsspanne: 2 years
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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
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2 years
|
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Assessment of the content of antibiotic resistance genes (resistome), virulence genes (virulome), and plasmids (percentage of presence).
Tijdsspanne: 2 years
|
Resistome, virulome and plasmids will be measured as percentages in each strain identified.
|
2 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Antibiotic resistance phenotype:
Tijdsspanne: 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
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2 years
|
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Study of bacterial growth curves for the main identified clones
Tijdsspanne: 2 years
|
Growth curves will be compared using the Gompertz nonlinear regression model with GraphPad Prism 9.2 software (San Diego, CA, USA).
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2 years
|
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Study of biofilm formation (Bioflux 200TM system) for the main identified clones,
Tijdsspanne: 2 years
|
The Bioflux 200TM system will be used to study biofilm formation
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2 years
|
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Study of bacterial motility (swimming, swarming) for the main identified clones
Tijdsspanne: 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.
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2 years
|
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Performance of eHRB screening media on carbapenemase-producing E. coli strains
Tijdsspanne: 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.
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2 years
|
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Risk factors for infections caused by carbapenemase-producing E. coli. : Age
Tijdsspanne: 2 years
|
Age will be recorded in years with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
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2 years
|
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Risk factors for infections caused by carbapenemase-producing E. coli. : Sex
Tijdsspanne: 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.
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2 years
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Risk factors for infections caused by carbapenemase-producing E. coli. : Department of residence
Tijdsspanne: 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.
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2 years
|
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Risk factors for infections caused by carbapenemase-producing E. coli. : Medical history
Tijdsspanne: 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.
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2 years
|
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Risk factors for infections caused by carbapenemase-producing E. coli. : Type of infection
Tijdsspanne: 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.
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2 years
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Risk factors for infections caused by carbapenemase-producing E. coli. : Comorbidities
Tijdsspanne: 2 years
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Comorbidities will be recorded with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
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2 years
|
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Risk factors for infections caused by carbapenemase-producing E. coli. : Length of hospital stay
Tijdsspanne: 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.
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2 years
|
|
Risk factors for infections caused by carbapenemase-producing E. coli. : Invasive devices
Tijdsspanne: 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
|
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Risk factors for infections caused by carbapenemase-producing E. coli. : Surgery
Tijdsspanne: 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.
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2 years
|
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Risk factors for infections caused by carbapenemase-producing E. coli. : Antibiotic exposure
Tijdsspanne: 2 years
|
Antibiotic exposure will be recorded with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
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2 years
|
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Risk factors for infections caused by carbapenemase-producing E. coli. : Repeat hospitalizations
Tijdsspanne: 2 years
|
Repeat hospitalizations will be recorded with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
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2 years
|
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Risk factors for infections caused by carbapenemase-producing E. coli. : Recent travel
Tijdsspanne: 2 years
|
Recent travel will be recorded with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
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2 years
|
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Risk factors for infections caused by carbapenemase-producing E. coli. : Inter-hospital transfers
Tijdsspanne: 2 years
|
Inter-hospital transfers will be recorded with the aim of identifying possible risk factors for infections caused by carbapenemase-producing E. coli.
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2 years
|
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Risk factors for infections caused by carbapenemase-producing E. coli. : Cross-transmission
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Infecties
- Bacteriële infecties
- Bacteriële infecties en mycosen
- Gram-negatieve bacteriële infecties
- Escherichia coli-infecties
- Enterobacteriaceae-infecties
- Onderzoekstechnieken
- Klinische laboratoriumtechnieken
- Diagnostische technieken en procedures
- Diagnose
- Genetische technieken
- Sequentie -analyse
- Sequentie -analyse, DNA
- Microbiologische technieken
- Molecular Typing
- Bacterial Typing Techniques
- Bacteriological Techniques
- Multilocus Sequence Typing
Andere studie-ID-nummers
- NIMAO/2025-2/AP-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
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