Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506318
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
A Joint Model Based on Deep Learning to Predict Multidrug-resistant Klebsiella Pneumoniae Liver Abscess
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Combining Image-clinical Model Based on Deep Learning and Radiomics to Predict Multidrug-resistant Klebsiella Pneumoniae Liver Abscess
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLASS2401
Brief Summary:
The goal of this observational study is to train a deep learning-based model to predict multidrug-resistant Klebsiella pneumoniae liver abscess and evaluate it on a multi-center database
Detailed Description:
Liver abscess is one of the most common abdominal organ infections worldwide with a mortality rate that once reached as high as 70 Before the widespread use of antibiotics suppurative appendicitis was the main causative factor for liver abscesses In recent years with the widespread application of antibiotics and the promotion and popularization of interventional therapy the main causative factor for liver abscesses has gradually shifted from suppurative appendicitis to biliary tract diseases and the mortality rate of liver abscesses has also been gradually declining However due to the increasing number of infections caused by various multidrug-resistant organisms MDROs the reported mortality rate currently remains between 2 and 18
In the treatment of liver abscesses it is very important to apply antibiotic therapy as early and as quickly as possible after diagnosis Particularly in China with its large population and varying medical conditions across different regions for many primary medical institutions that lack the ability to carry out interventional treatments antibiotic therapy is the only means of treating such infectious diseases as liver abscesses However precise antibiotic therapy relies on the results of bacterial cultures and drug susceptibility tests Because many patients have received treatment at other medical institutions or have self-administered antibiotics before coming to the hospital the results of blood cultures are somewhat affected Currently the common pathogens of community-acquired liver abscesses are mainly Gram-negative enterobacteria among which Klebsiella pneumoniae KP and Escherichia coli are the majority with a major shift from Escherichia coli to Klebsiella pneumoniae In China Klebsiella pneumoniae has become the primary pathogen of community-acquired liver abscesses Therefore empirical treatment regimens typically prioritize the treatment of infections caused by Gram-negative enterobacteria especially KP However infections caused by MDROs often result in poor or directly ineffective treatment due to resistance to empirically chosen antibiotics thereby delaying treatment causing greater economic burdens on patients and consuming more medical resources Infections caused by MDROs have become a global public health issue of great concern The increasing occurrence of MDRO infections and the emergence of new types of MDROs pose higher demands on clinical physicians Under this new trend of pathogenic bacteria it is unacceptable to rely solely on empirical diagnostic and treatment methods but need efficient and convenient new ways to guide the selection of clinical treatment regimens
Among MDRO infections in liver abscess patients the largest proportion is caused by extended-spectrum beta-lactamase ESBL-producing enterobacteria mainly ESBL-producing Klebsiella pneumoniae and Escherichia coli Therefore if it could be based on general understanding on the most predominant Gram-negative bacteria and explore the clinical manifestations biochemical indicators CT images and other characteristics and differences between liver abscesses caused by Gram-negative enterobacteria and other types of pathogens the differences between ESBL bacteria and other non-resistant bacteria as well as other MDROs within Gram-negative bacteria would be explored Ultimately constructing a predictive model that can identify the types of pathogenic bacteria and the presence of MDROs in the early stages of the disease through basic clinical characteristics laboratory indicators and CT images would have significant theoretical and practical value
In the treatment of liver abscesses it is very important to apply antibiotic therapy as early and as quickly as possible after diagnosis Particularly in China with its large population and varying medical conditions across different regions for many primary medical institutions that lack the ability to carry out interventional treatments antibiotic therapy is the only means of treating such infectious diseases as liver abscesses However precise antibiotic therapy relies on the results of bacterial cultures and drug susceptibility tests Because many patients have received treatment at other medical institutions or have self-administered antibiotics before coming to the hospital the results of blood cultures are somewhat affected Currently the common pathogens of community-acquired liver abscesses are mainly Gram-negative enterobacteria among which Klebsiella pneumoniae KP and Escherichia coli are the majority with a major shift from Escherichia coli to Klebsiella pneumoniae In China Klebsiella pneumoniae has become the primary pathogen of community-acquired liver abscesses Therefore empirical treatment regimens typically prioritize the treatment of infections caused by Gram-negative enterobacteria especially KP However infections caused by MDROs often result in poor or directly ineffective treatment due to resistance to empirically chosen antibiotics thereby delaying treatment causing greater economic burdens on patients and consuming more medical resources Infections caused by MDROs have become a global public health issue of great concern The increasing occurrence of MDRO infections and the emergence of new types of MDROs pose higher demands on clinical physicians Under this new trend of pathogenic bacteria it is unacceptable to rely solely on empirical diagnostic and treatment methods but need efficient and convenient new ways to guide the selection of clinical treatment regimens
Among MDRO infections in liver abscess patients the largest proportion is caused by extended-spectrum beta-lactamase ESBL-producing enterobacteria mainly ESBL-producing Klebsiella pneumoniae and Escherichia coli Therefore if it could be based on general understanding on the most predominant Gram-negative bacteria and explore the clinical manifestations biochemical indicators CT images and other characteristics and differences between liver abscesses caused by Gram-negative enterobacteria and other types of pathogens the differences between ESBL bacteria and other non-resistant bacteria as well as other MDROs within Gram-negative bacteria would be explored Ultimately constructing a predictive model that can identify the types of pathogenic bacteria and the presence of MDROs in the early stages of the disease through basic clinical characteristics laboratory indicators and CT images would have significant theoretical and practical value
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None