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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Shengjing hospital of China medical university

    Shenyang, Liaoning, 110004

    Zhihui Chang, Changzh@sj-hospital.org

    Recruiting

Other trials in China

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 groups in NCT06506318
Study groupRoleWhat they receive
Patients with ESBL(-) liver abscessNot described
Patients with ESBL(+) liver abscessNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  2. 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.

  1. First posted17 Jul 2024
  2. Study start1 Jan 2024
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion1 Mar 2025 (estimated)

Resources

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)
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

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.

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