NCT05521139

Brief Summary

Pyogenic liver abscess (PLA) is a complication of infectious disease, and the most common pathogen of PLA is Klebsiella pneumoniae, while PLA caused by Carbapenem-resistant Klebsiella pneumoniae (CRKP) has become a threat to public health. For achieving a better therapeutic outcome of CRKP related PLA, it is very important to figure out the basic characteristics and risk factors of CRKP-PLA. A retrospective cohort study was performed in which 15 PLA patients carriage of K pneumoniae were screened at the Xiangya hospital of central south university (changsha, China). The colonization and clinical infection isolates were analyzed by antimicrobial susceptibility testing to identify CRKP. All admission patients diagnosed with PLA who developed CRKP were included, 5 adults PLA patients with CRKP infected and 10 adults PLA patients with Carbapenem sensitive Klebsiella pneumoniae (CSKP) infected were conducted. Univariate and multivariate logistic regression was carried out using a stepwise selection method to compare prognostic factors between CRKP and CSKP groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
Last Updated

August 30, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

August 29, 2022

Last Update Submit

August 29, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • the survival rates

    2monthes

Study Arms (2)

CRKP-PLA

Klebsiella pneumoniae were isolated from pyogenic liver abscess patients' blood or pus and the antibiotic drug sensitivity results shows it is carbapenem-resistant Klebsiella pneumoniae.

Diagnostic Test: drug sensitivity results

CSKP-PLA

Klebsiella pneumoniae were isolated from pyogenic liver abscess patients' blood or pus and the antibiotic drug sensitivity results shows it is carbapenem-sensitive Klebsiella pneumoniae.

Diagnostic Test: drug sensitivity results

Interventions

drug sensitivity results including the carbapenem-resistant Klebsiella pneumoniae and carbapenem-sensitive Klebsiella pneumoniae

CRKP-PLACSKP-PLA

Eligibility Criteria

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

18 years of age or older and at least one positive culture reported by the clinical microbiology laboratory for CRKP or CSKP during the hospital length of stay. Klebsiella pneumoniae were isolated and identified in the blood or pus with antibiotic drug sensitivity results.

You may qualify if:

  • years of age or older. at least one positive culture reported by the clinical microbiology laboratory for CRKP or CSKP during the hospital length of stay.
  • Klebsiella pneumoniae were isolated and identified in the blood or pus with antibiotic drug sensitivity results.

You may not qualify if:

  • Less than 18 years old. patients with missing data without a drug sensitivity results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinqing Liu

Changsha, China

Location

MeSH Terms

Conditions

Liver Abscess

Condition Hierarchy (Ancestors)

Abdominal AbscessAbscessSuppurationInfectionsLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2022

First Posted

August 30, 2022

Study Start

April 1, 2020

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

August 30, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations