Clinical Outcomes of Hypervirulent Carbapenem-resistant Klebsiella Pneumoniae Infection

NCT ID: NCT06190548

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 556 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2023-06-30

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.

Conditions

Infection, Bacterial

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

cCRKP

Patients with classic CRKP infection

No interventions assigned to this group

hvCRKP

Patients with hypervirulent CRKP infection

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ya Hu

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Center of infectious diseases

Role: STUDY_DIRECTOR

West China Hospital

Locations

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Countries

China

Other Identifiers

81861138055

Identifier Type: OTHER

Identifier Source: secondary_id

SichuanU

Identifier Type: -

Identifier Source: org_study_id