Hypervirulent Amoxicillin-Susceptible Klebsiella Pneumoni... | NCT07598006

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

NCT07598006

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

May 20, 2026Actual

Enrollment

56Actual

Phase

Not provided

Conditions

Sepsis
Infections

Interventions

Bacterial species identification by Whole Genome sequencing

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Dec 12, 2023Actual

Completion Date

Dec 12, 2025Actual

First Submitted Date

May 13, 2026

First Submission Date that Met QC Criteria

May 13, 2026

First Posted Date

May 20, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2026

Last Update Posted Date

May 20, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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."

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

56Actual

Name	Type	Description	Arm Group Labels	Other Names
Bacterial species identification by Whole Genome sequencing	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de NICE		Nice	Alpes Maritimes	06000	France

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D007239	Infections

Ancestor Terms

ID	Term
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided