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Prospective Study of Multi-centers Exploring the Difference of Clinical Impact by Using Respiratory Pathogen ID/AMR Panel (RPIP) Versus Untarget Metagenomic Next-generation Sequencing (mNGS) and Multiplex PCR in Pathogen Identification of Pneumonia Patients in Intensive Care Unit

29. maj 2026 opdateret af: Yu-Chao Lin, China Medical University Hospital

h Can Provide the Detection Results of Pathogen Type and Resistant Gene. This Study is a Prospective Multi Centers Study to Explore Using the New Diagnostic Tool of " RPIP " and the Different Detection Methods of Next Generation Sequencing and Multiplex PC R in Patients With Pneumonia in ICU. Further Compare the Difference of Pathogen Identification and Clinical Impact by Different Diagnostic Methods.

Pneumonia, pathogen involved to lower respiratory tract and leading lung parenchyma infection, is one of the three most common infectious diseases in the world. Rapidly and correctly diagnosis and prescription could reduce the complication, length of hospitalization and mortality rate, especially for the critically patients in intensive care unit. Among the current microbiological diagnostic methods, the current traditional culture combined with biochemical identification method is easily affected by the drug using and different species, and time consuming. Although other diagnostic methods like MALDI-TOF MS、multiplex PCR also common and available in clinically, but owing some limitations like lower resolution, inability to afford the drug sensitivity of pathogen. Whole genome sequencing is one of the potential developing tools in pathogen identification, especially the next-general sequencing. The advantage of Metagenomic NGS (mNGS) in the application of clinical microbial detection is that it can identify various species and provide drug resistance gene information at the same time. However, background DNA from non-pathogens can highly affect the sensitivity of next-generation sequencing (untargeted mNGS). The Respiratory Pathogen ID/AMR Panel (RPIP) is a targeted mNGS developed by Illumina, which can provide the detection results of pathogen type and resistant gene. This study is a prospective multi-centers study to explore using the new diagnostic tool of " RPIP " and the different detection methods of next-generation sequencing and multiplex PCR in patients with pneumonia in ICU. Further compare the difference of pathogen identification and clinical impact by different diagnostic methods.

Studieoversigt

Status

Tilmelding efter invitation

Undersøgelsestype

Observationel

Tilmelding (Anslået)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Taichung, Taiwan, 40447
        • Biomedical Technology R&D Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

ICU pneumonia patients

Beskrivelse

Inclusion Criteria:

  • Patients admitted to the intensive care unit who meet the diagnosis of pneumonia

Exclusion Criteria:

  • Under 18 years old

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
ICU pneumonia patient

Standard-of-care test: Bacterial and fungal testing: BAL and ETA or sputum specimens are subjected to Gram staining, and aerobic, anaerobic, and fungal cultures are performed. Mycobacterium culture is performed, and PCR is used to detect mycobacterial DNA. Other tests included atypical pathogen, aspergillus and virus survey.

FilmArray PP can detect 15 bacterial species, 3 atypical bacteria, 8 viruses, and detect 7 antimicrobial resistance genes.

Respiratory Pathogen ID/AMR enrichment (RPIP): According to the manufacturer's instructions, the workflow includes nucleic acid extraction, cDNA synthesis, sequencing library construction, target amplification, library quality testing, sequencing, and analysis.

Untargeted mNGS: The sample is outsourced to a biotechnology company for mNGS analysis.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The expected outcomes to validate the effectiveness of RPIP application in the treatment of pneumonia patients in intensive care units, and to evaluate the value of this method in pathogen identification and clinical treatment decision-making.
Tidsramme: After obtaining informed consent, samples will be collected from ICU patients with severe pneumonia at that hospitalization.
The turnaround time between RPIP results and the final report of the standard test is compared to evaluate the time saved by using RPIP. The proportion of clinical treatment strategy adjustments prompted by RPIP results is analyzed, as well as the proportion of inappropriate empirical treatments. It also analyzes whether adjustments in treatment strategies have an impact on mortality.
After obtaining informed consent, samples will be collected from ICU patients with severe pneumonia at that hospitalization.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Generalization medical information
Tidsramme: Collect data admission period, 28-day and 90-day mortality.
The data will collect from the medical records of patients, which contained demographic data (age, gender, smoking status, alcohol consumption, source of admission, and type of ICU and supportive care), comorbidities (malignancy, liver disease, including chronic hepatitis or cirrhosis, heart failure, hypertension, cerebral vascular disease, neurodegenerative disorder, chronic kidney disease, chronic lung disease, diabetes mellitus, immunocompromised due to long-term use of steroid or other immunosuppressants, autoimmune disease), clinical manifestations, laboratory findings, severity of illness on the day of pneumonia diagnosis evaluated by the Acute Physiology and Chronic Health Evaluation (APACHE) II score and SOFA score, microbiological profile, antimicrobial therapy, and other outcome measures included 90-day mortality, clinical cure/improvement, and microbiological eradication at day 14 following pneumonia diagnosis evaluation.
Collect data admission period, 28-day and 90-day mortality.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. november 2023

Primær færdiggørelse (Anslået)

9. april 2028

Studieafslutning (Anslået)

9. april 2028

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

29. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CMUH112-REC1-087

Plan for individuelle deltagerdata (IPD)

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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