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Completed

NCT Number: NCT06190548

Clinical Outcomes of Hypervirulent Carbapenem-resistant Klebsiella Pneumoniae Infection

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.

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Key information

Conditions

Infection, Bacterial Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 30-day mortality

    Time frame: 30 days

    The mortality of patients 30-days after CRKP infection

  2. The number of participants with status

    Time frame: 30 days

    The status of patients 30 days after CRKP infection, including death, no response or progress, and remission.

Secondary outcomes

  1. length of stay (LOS) in the hospital

    Time frame: 30 days

    length of stay of the patients

  2. post-infection survival

    Time frame: 30 days

    Survival of patients after CRKP infection

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Acronym: HVCRKP

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jan 5, 2024
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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