SepsisNCT07598006
Hypervirulent Amoxicillin-Susceptible Klebsiella Pneumoniae CC66, France, 2016-2023
An observational study of Sepsis and Infections, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis, Infections
- What is being tested?
- Bacterial species identification by Whole Genome sequencing
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2016to 12 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Klebsiella pneumoniae infection treated at a university hospital in France between 2016 and 2023.
Who may be able to join
- Patients with confirmed Klebsiella pneumoniae infection.
- Isolates collected between 2016 and 2023.
- Isolates with confirmed susceptibility to amoxicillin.
Who cannot join
- Isolates not confirmed as Klebsiella pneumoniae.
- Isolates without antimicrobial susceptibility confirmation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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."
- Conditions
- Sepsis, Infections
- Being tested
- Bacterial species identification by Whole Genome sequencing
- Medical subject headings
- Sepsis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacterial species identification by Whole Genome sequencingBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At isolate collection and genomic analysis (2016-2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Jan 2016
- Primary completion12 Dec 2023
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598006
- Sponsor's protocol ID
- 26Labo02
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic and Clinical Characterization of Amoxicillin-Susceptible Klebsiella Pneumoniae, Including Hypervirulent Clonal Complex 66, in a French University Hospital (2016-2023)
- ClinicalTrials.gov ID
- NCT07598006
- Acronym / sponsor ID
- 26Labo02
- Conditions
- Sepsis, Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Klebsiella pneumoniae infection treated at a university hospital in France between 2016 and 2023.
Key inclusion criteria (3 listed)
- Patients with confirmed Klebsiella pneumoniae infection.
- Isolates collected between 2016 and 2023.
- Isolates with confirmed susceptibility to amoxicillin.
Key exclusion criteria (2 listed)
- Isolates not confirmed as Klebsiella pneumoniae.
- Isolates without antimicrobial susceptibility confirmation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacterial species identification by Whole Genome sequencing | Biological | – |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Infections, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.