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OpenTrials
Completed

NCT Number: NCT07598006

Hypervirulent Amoxicillin-Susceptible Klebsiella Pneumoniae CC66, France, 2016-2023

"Klebsiella pneumoniae is considered intrinsically resistant to ampicillin because of the chromosomal blaSHV β-lactamase. However, amoxicillin-susceptible isolates have been sporadically reported. This retrospective observational study analyzes amoxicillin-susceptible K. pneumoniae isolates collected between 2016 and 2023 at a university hospital in France. Whole-genome sequencing, phylogenetic analysis, and virulence and resistance profiling were performed, and clinical data were reviewed. The study aims to characterize the genomic mechanisms underlying amoxicillin susceptibility and to assess associations with specific lineages, particularly hypervirulent clonal complex 66 (CC66), and clinical features."

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de NICE

Nice, Alpes Maritimes, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with confirmed Klebsiella pneumoniae infection.
  • Isolates collected between 2016 and 2023.
  • Isolates with confirmed susceptibility to amoxicillin.

Exclusion criteria

  • Isolates not confirmed as Klebsiella pneumoniae.
  • Isolates without antimicrobial susceptibility confirmation.

Treatment and study plan

Bacterial species identification by Whole Genome sequencing

Biological

Primary outcomes

  1. Assessment of blaSHV gene status (presence, deletion, or disruptive mutations) by whole-genome sequencing and its association with amoxicillin susceptibility.

    Time frame: At isolate collection and genomic analysis (2016-2023)

    Whole-genome sequencing was used to determine blaSHV gene status (presence, absence, or disruptive mutations)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Genomic and Clinical Characterization of Amoxicillin-Susceptible Klebsiella Pneumoniae, Including Hypervirulent Clonal Complex 66, in a French University Hospital (2016-2023)

Important dates

Study start
2016
Primary completion
2023
Study completion
2025
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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