NCT06190548

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
556

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

January 5, 2024

Status Verified

December 1, 2023

Enrollment Period

3 years

First QC Date

December 19, 2023

Last Update Submit

January 3, 2024

Conditions

Infection, Bacterial

Keywords

Klebsiella pneumoniaehypervirulentclinical outcome

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • length of stay (LOS) in the hospital

    30 days

  • post-infection survival

    30 days

Study Arms (2)

cCRKP

Patients with classic CRKP infection

hvCRKP

Patients with hypervirulent CRKP infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with CRKP infection

You may qualify if:

  • Adult patients (≥18-year-old) with CRKP infections were included.

You may not qualify if:

  • younger than 18 years old; clinical samples were identified to contain CRKP but were sentenced to be colonization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Clinical samples which were identified as containing CRKP

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Center of infectious diseases

    West China Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 5, 2024

Study Start

July 1, 2019

Primary Completion

July 1, 2022

Study Completion

June 30, 2023

Last Updated

January 5, 2024

Record last verified: 2023-12

Locations

CN(1)