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. Mai 2026 aktualisiert von: 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.
Studienübersicht
Status
Anmeldung auf Einladung
Bedingungen
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
200
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Taichung, Taiwan, 40447
- Biomedical Technology R&D Center
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
ICU pneumonia patients
Beschreibung
Inclusion Criteria:
- Patients admitted to the intensive care unit who meet the diagnosis of pneumonia
Exclusion Criteria:
- Under 18 years old
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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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.
Zeitfenster: After obtaining informed consent, samples will be collected from ICU patients with severe pneumonia at that hospitalization.
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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.
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After obtaining informed consent, samples will be collected from ICU patients with severe pneumonia at that hospitalization.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Generalization medical information
Zeitfenster: Collect data admission period, 28-day and 90-day mortality.
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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.
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Collect data admission period, 28-day and 90-day mortality.
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
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Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
20. November 2023
Primärer Abschluss (Geschätzt)
9. April 2028
Studienabschluss (Geschätzt)
9. April 2028
Studienanmeldedaten
Zuerst eingereicht
21. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. Mai 2026
Zuerst gepostet (Tatsächlich)
4. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- CMUH112-REC1-087
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