Clinical Outcomes of Hypervirulent Carbapenem-resistant Klebsiella Pneumoniae Infection

Infection, Bacterial Clinical Trial

— HVCRKP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06190548
• Other study ID #: SichuanU
• Secondary ID: 81861138055
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2023
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 556
• Est. completion date: June 30, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection, Bacterial
• Infections
• Klebsiella Infections
• Pneumonia

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality	The mortality of patients 30-days after CRKP infection	30 days
Primary	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	length of stay (LOS) in the hospital	length of stay of the patients	30 days
Secondary	post-infection survival	Survival of patients after CRKP infection	30 days