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

May 13, 2026 updated by: Centre Hospitalier Universitaire de Nice

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 06000
        • CHU de Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Klebsiella pneumoniae infection treated at a university hospital in France between 2016 and 2023.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At isolate collection and genomic analysis (2016-2023)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 12, 2023

Study Completion (Actual)

December 12, 2025

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26Labo02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infections

Clinical Trials on Bacterial species identification by Whole Genome sequencing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe