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

NCT07598006 | Completed

• 1 other identifier: 26Labo02
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

"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."

Conditions

Sepsis; Infections

Outcome Measures

Primary Outcomes (1)

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

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

  At isolate collection and genomic analysis (2016-2023)

Interventions

Bacterial species identification by Whole Genome sequencing BIOLOGICAL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de NICE

Nice, Alpes Maritimes, 06000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Only the bacteial strains (isolated from patients blood culture samples were retained. Only bacterial DNA was extractable from these samples and not patient DNA.

MeSH Terms

Conditions

Sepsis; Infections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 20, 2026
• Study Start: January 1, 2016
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2025
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

FR (1)