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Clinical Outcomes of Hypervirulent Carbapenem-resistant Klebsiella Pneumoniae Infection (HVCRKP)

S

Sichuan University

Status

Completed

Conditions

Infection, Bacterial

Study type

Observational

Funder types

Other

Identifiers

NCT06190548
81861138055 (Other Identifier)
SichuanU

Details and patient eligibility

About

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.

Full 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.

Enrollment

556 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

556 participants in 2 patient groups

cCRKP
Description:
Patients with classic CRKP infection
hvCRKP
Description:
Patients with hypervirulent CRKP infection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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