Skip to content

Optimization of molecular diagnostic methods workflow for pathogens in hospitalized patients with pneumonia

Optimization of molecular diagnostic methods workflow for pathogens in hospitalized patients with pneumonia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084276
Enrollment
Unknown
Registered
2024-05-14
Start date
2024-05-17
Completion date
Unknown
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Interventions

Experimental group:In the experimental group, the AI identification model was used to screen suspected pathogens, and combined with the previous test results, the highly sensitive specimens and detect
Control group1: In the control group, the test package was randomly selected (the treating physicians were aware of the protocol and the results). Participants in Control group1 will have NGS (local l
Control group2:Participants in Control group 2 will have tNGS (sent to JinYu laboratories for testing).
Control group3:Participants in Control group 3 will have TAC testing (local laboratory).

Sponsors

Zhongshan hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: ? Hospitalized patients over 18 years old with suspected pulmonary infection on chest imaging ? For the exploratory study, patients should meet the following requirements: a. It is necessary to identify the pathogen as soon as possible if the pathogen is suspected to be infected with a special pathogen, or if the traditional microbiological detection technology is repeatedly negative and the treatment effect is not good, or if the special patient is repeatedly hospitalized with immunosuppression b. Severe or rapidly progressive cases showed no improvement in imaging after formal anti-infection treatment for more than 1 week; Chronic patients had no improvement in imaging after formal anti-infection for more than 1 month

Exclusion criteria

Exclusion criteria: ? Age =18 years old ? patients with clinical or etiological diagnosis of viral pulmonary infection ? Pathological examination of the lesion suggested tumor, rheumatic disease and vascular disease ? presence of any conditions that may interfere with study procedures and compliance (based on clinician judgment) ? The results of genetic testing were not up to standard

Design outcomes

Primary

MeasureTime frame
Whether the patient's antibiotic treatment plan changed due to the test results. ;Sensitivity of method in Experimental group;Specificity of method in Control group;

Secondary

MeasureTime frame
The outcome of pulmonary infection (improved, unimproved, deteriorated) was followed up for 1 month.;

Countries

China

Contacts

Public ContactHu bijie

Zhongshan hospital of Fudan University

hu.bijie@zs-hospital.sh.cn+86 136 0162 1604

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026