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

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

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.

Study Overview

• Status: Completed
• Conditions: Infection, Bacterial

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.

• Study Type: Observational
• Enrollment (Actual): 556

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with CRKP infection

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
cCRKP; Patients with classic CRKP infection
hvCRKP; Patients with hypervirulent CRKP infection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Study Director: Center of infectious diseases, West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: clinical outcome; Klebsiella pneumoniae; hypervirulent
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Infections; Communicable Diseases; Pneumonia; Bacterial Infections; Klebsiella Infections
• Other Study ID Numbers: SichuanU; 81861138055 (Other Identifier: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The original data might be shared in the form of an article attachment, but it was not decided for now.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No