NCT06661499

Brief 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 detection of pathogenic bacteria and other clinical parameter variables of patients.

Trial Health

63
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Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress50%
Jan 2025Dec 2027

First Submitted

Initial submission to the registry

September 5, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 28, 2024

Status Verified

August 1, 2024

Enrollment Period

2.9 years

First QC Date

September 5, 2024

Last Update Submit

October 24, 2024

Conditions

Keywords

pneumoniacolonizationinfectionartificial neural network modelintensive care unit

Outcome Measures

Primary Outcomes (1)

  • 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.

    day1,day3 and day7 after enrollment

Interventions

to establish an artificial neural network model for pathogen diagnosis in ICU pneumonia

Eligibility Criteria

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

Pneumonia patients who admitted to Nanjing Drum Tower Hospital from Jan 1,2025 to Dec 31,2027 and meet the inclusion criteria.

You may qualify if:

  • 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.

You may not qualify if:

  • pregnant women;
  • lactating women;
  • patients who could not obtain lower respiratory specimens;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

PneumoniaInfections

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yan Wang, Master

    Nanjing Drum Tower Hosptial

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Wang, Master

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2024

First Posted

October 28, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

October 28, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations