PneumoniaNCT06661499
An Observational Clinical Study on the Construction of an Artificial Neural Network Model for ICU Pneumonia
An observational study of Pneumonia, run by Chinese Medical Association at 1 site in China.
Trial summary
To achieve rapid, intelligent and accurate microbiological diagnosis and treatment for ICU pneumonia, an artificial neural network model for microbiological diagnosis is established, which depends on many clinical cases and machine deep learning from clinical experts' judgements according to species-specific rapid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- establish an artificial neural network model
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Jan 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Pneumonia patients who admitted to Nanjing Drum Tower Hospital from Jan 1,2025 to Dec 31,2027 and meet the inclusion criteria.
Who may be able to join
- aged ≥18 years;
- agreed to obtain lower respiratory specimens for rapid testing of pathogenic bacteria;
- all were enrolled by an experienced physician who dynamically determined that the microorganisms were in a colonised or infected state;
- signed an informed consent form.
Who cannot join
- pregnant women;
- lactating women;
- patients who could not obtain lower respiratory specimens;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Yan Wang, Master, +86 18905150275, a_nengneng@163.com
About this study
Official title: An Observational Clinical Study on the Construction of an Artificial Neural Network Model for Rapid Intelligent Diagnosis of Microorganisms in ICU Pneumonia Based on Species-specific Rapid Detection of Pathogenic Bacteria
To achieve rapid, intelligent and accurate microbiological diagnosis and treatment for ICU pneumonia, an artificial neural network model for microbiological diagnosis is established, which depends on many clinical cases and machine deep learning from clinical experts' judgements according to species-specific rapid detection of pathogenic bacteria and other clinical parameter variables of patients.
Read the detailed description
This study is a prospective single-centre observational study, 600 ICU pneumonia patients are expected to be selected as the observation object, and the lower respiratory secretions of patients on d1, d3 and d7 after enrollment are collected for species-specific rapid detection and microbial culture, while the general information of the patients and the clinical information of the corresponding time points on d1, d3 and d7 are collected. Two experienced senior physicians were organized to determine whether the microbial results were colonized or infected, and an artificial neural network model for rapid and intelligent diagnosis of pathogenic microorganisms in ICU pneumonia will be established and validated through multi-dimensional machine learning.
- Conditions
- Pneumonia
- Being tested
- establish an artificial neural network model
- Keywords
- pneumonia, colonization, infection, artificial neural network model, intensive care unit
- Medical subject headings
- Pneumonia, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
establish an artificial neural network modelOther
to establish an artificial neural network model for pathogen diagnosis in ICU pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical evaluation of each microbial detected whether in colonization or infection
Two experienced senior physicians are organized to determine whether the microbial are colonized or infected according to clinical values.
Measured: day1,day3 and day7 after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Yan Wang, Master, Principal investigator, Nanjing Drum Tower Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661499
- Sponsor's protocol ID
- 2024-607-01
- Status last verified
- Aug 2024
- First submitted
- 5 Sep 2024
- Last updated
- 28 Oct 2024
- Results posted
- 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 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Clinical Study on the Construction of an Artificial Neural Network Model for Rapid Intelligent Diagnosis of Microorganisms in ICU Pneumonia Based on Species-specific Rapid Detection of Pathogenic Bacteria
- ClinicalTrials.gov ID
- NCT06661499
- Acronym / sponsor ID
- 2024-607-01
- Conditions
- Pneumonia
- Keywords
- pneumonia, colonization, infection, artificial neural network model, intensive care unit
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Oct 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.
To achieve rapid, intelligent and accurate microbiological diagnosis and treatment for ICU pneumonia, an artificial neural network model for microbiological diagnosis is established, which depends on many clinical cases and machine deep learning from clinical experts' judgements according to species-specific rapid detection of pathogenic bacteria and other clinical parameter variables of patients.
Detailed description
This study is a prospective single-centre observational study, 600 ICU pneumonia patients are expected to be selected as the observation object, and the lower respiratory secretions of patients on d1, d3 and d7 after enrollment are collected for species-specific rapid detection and microbial culture, while the general information of the patients and the clinical information of the corresponding time points on d1, d3 and d7 are collected. Two experienced senior physicians were organized to determine whether the microbial results were colonized or infected, and an artificial neural network model for rapid and intelligent diagnosis of pathogenic microorganisms in ICU pneumonia will be established and validated through multi-dimensional machine learning.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pneumonia patients who admitted to Nanjing Drum Tower Hospital from Jan 1,2025 to Dec 31,2027 and meet the inclusion criteria.
Key inclusion criteria (4 listed)
- aged ≥18 years;
- agreed to obtain lower respiratory specimens for rapid testing of pathogenic bacteria;
- all were enrolled by an experienced physician who dynamically determined that the microorganisms were in a colonised or infected state;
- signed an informed consent form.
Key exclusion criteria (3 listed)
- pregnant women;
- lactating women;
- patients who could not obtain lower respiratory specimens;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| establish an artificial neural network modelto establish an artificial neural network model for pathogen diagnosis in ICU pneumonia | Other | – |
Primary outcome
clinical evaluation of each microbial detected whether in colonization or infection
Time frame: day1,day3 and day7 after enrollment
Two experienced senior physicians are organized to determine whether the microbial are colonized or infected according to clinical values.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 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.
Yan Wang, Master principal investigator
Nanjing Drum Tower Hosptial
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 Pneumonia, run by Chinese Medical Association 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 28 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Wang, Master (+86 18905150275, a_nengneng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical evaluation of each microbial detected whether in colonization or infection (time frame: day1,day3 and day7 after enrollment). 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 28 Oct 2024.