Clinical Outcomes of Hypervirulent Carbapenem-resistant Klebsiella Pneumoniae Infection

Clinical Outcomes of Hypervirulent Carbapenem-resistant Klebsiella Pneumoniae Infection: a Single-centre Cohort Study With Multiplex Analyses in China

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06190548

Acronym

HVCRKP

Enrollment

556

Registered

2024-01-05

Start date

2019-07-01

Completion date

2023-06-30

Last updated

2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Bacterial

Keywords

Klebsiella pneumoniae, hypervirulent, clinical outcome

Brief summary

The goal of this observational study is to learn about the risk factors of mortality for CRKP infected patients, and to compare the clinical outcomes between hvCRKP infection and cCRKP infection. The main question it aims to answer is • Whether hypervirulence would add value to cCRKP infection and cause worse outcomes? Participants data will be collected through medical records.

Detailed description

We conducted an observational cohort study comprising three-year (2019-2022) data in a Chinese university hospital. We performed genome sequencing for CRKP strains, compared adult patients infected by hvCRKP with those by non-hypervirulent classical CRKP (cCRKP), and used propensity score matching (PSM) for imbalanced baseline characteristics. We defined 30-day all-cause and attributed mortalities and 30-day ranking outcomes (death, no response/progress, remission) as primary outcomes and post-infection stay and survival as secondary outcomes. We constructed mortality-predicting models and performed subgroup analyses for CRKP of the dominant sequence or capsular type or with varied virulence profiles and for patients with bloodstream or lower respiratory tract infections.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients (≥18-year-old) with CRKP infections were included.

Exclusion criteria

* younger than 18 years old; clinical samples were identified to contain CRKP but were sentenced to be colonization

Design outcomes

Primary

Measure	Time frame	Description
30-day mortality	30 days	The mortality of patients 30-days after CRKP infection
The number of participants with status	30 days	The status of patients 30 days after CRKP infection, including death, no response or progress, and remission.

Secondary

Measure	Time frame	Description
length of stay (LOS) in the hospital	30 days	length of stay of the patients
post-infection survival	30 days	Survival of patients after CRKP infection

Countries

China

Outcome results