Clinical Outcomes of Hypervirulent Carbapenem-resistant Klebsiella Pneumoniae Infection

Completed

• Conditions: Infection, Bacterial

• Registration Number: NCT06190548
• Lead Sponsor: West China Hospital

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.

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2022-07-01
• Study Completion: 2023-06-30
• Status Verified: 2023-12
• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2024-01-03
• Last Update Submitted: 2024-01-03
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 556

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China