Liver AbscessCLASS2401NCT06506318
A Joint Model Based on Deep Learning to Predict Multidrug-resistant Klebsiella Pneumoniae Liver Abscess
An observational study of Liver Abscess, run by Shengjing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Abscess
- How many people
- 550 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pyogenic liver abscess patients in 14years of a multicenter project.
Who may be able to join
- Patients diagnosed as pyogenic liver abscess and was proved by surgery or interventional process.
- Patients had accepted abdominal enhance CT scans before surgery or interventional process.
Who cannot join
- Patients diagnosed with other types of liver abscess such as amoeba.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shengjing hospital of China medical university
Shenyang, Liaoning, 110004
Zhihui Chang, Changzh@sj-hospital.org
About this study
Official title: Combining Image-clinical Model Based on Deep Learning and Radiomics to Predict Multidrug-resistant Klebsiella Pneumoniae Liver Abscess
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.
Read the 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.
- Conditions
- Liver Abscess
- Keywords
- Deep-learning; Liver Abscess
- Medical subject headings
- Liver Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ESBL(-) liver abscess | Not described | |
| Patients with ESBL(+) liver abscess | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Result of bacteria culture
The result of bacteria culture of abscess decides which group the patients belong. This result was obtained from bacteria culture tests which were done by department of laboratory medicine.
Measured: The first time before surgery or interventional process, usually within 1 week, up to 4 weeks.
Result of drug resistant test
Our destination is to find out the potential differences between Esbl(+) \& Esbl(-) liver abscess.
Measured: The first time before surgery or interventional process, usually within 1 week, up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Jan 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial), Guilin Medical University, China, Hebei General Hospital, Xijing Hospital, Hebei Medical University Third Hospital, The First Affiliated Hospital of Dalian Medical University, The People's Hospital of Liaoning Province, Fourth People's Hospital of Shenyang, Sir Run Run Shaw Hospital
- Responsible party
- Principal investigator, Zhihui Chang, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506318
- Sponsor's protocol ID
- 2024PS679K
- Acronym
- CLASS2401
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Image-clinical Model Based on Deep Learning and Radiomics to Predict Multidrug-resistant Klebsiella Pneumoniae Liver Abscess
- ClinicalTrials.gov ID
- NCT06506318
- Acronym / sponsor ID
- CLASS2401 / 2024PS679K
- Conditions
- Liver Abscess
- Keywords
- Deep-learning; Liver Abscess
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial), Guilin Medical University, China, Hebei General Hospital, Xijing Hospital, Hebei Medical University Third Hospital, The First Affiliated Hospital of Dalian Medical University, The People's Hospital of Liaoning Province, Fourth People's Hospital of Shenyang, Sir Run Run Shaw Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with ESBL(-) liver abscess | – | – |
| Patients with ESBL(+) liver abscess | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pyogenic liver abscess patients in 14years of a multicenter project.
Key inclusion criteria (2 listed)
- Patients diagnosed as pyogenic liver abscess and was proved by surgery or interventional process.
- Patients had accepted abdominal enhance CT scans before surgery or interventional process.
Key exclusion criteria (1 listed)
- Patients diagnosed with other types of liver abscess such as amoeba.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Result of bacteria culture
Time frame: The first time before surgery or interventional process, usually within 1 week, up to 4 weeks.
The result of bacteria culture of abscess decides which group the patients belong. This result was obtained from bacteria culture tests which were done by department of laboratory medicine.
Result of drug resistant test
Time frame: The first time before surgery or interventional process, usually within 1 week, up to 4 weeks.
Our destination is to find out the potential differences between Esbl(+) \& Esbl(-) liver abscess.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Abscess, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhihui Chang (+86 18940258437, Changzh@sj-hospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Result of bacteria culture (time frame: The first time before surgery or interventional process, usually within 1 week, up to 4 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.