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

Official title

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.

Overview

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.

Primary outcome measures

• 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. [Time frame: After obtaining informed consent, samples will be collected from ICU patients with severe pneumonia at that hospitalization.]

Secondary outcome measures (1)

• Generalization medical information [Time frame: Collect data admission period, 28-day and 90-day mortality.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• Under 18 years old

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Taiwan · 1 center

• Biomedical Technology R&D Center — Taichung

Publications

• Rodrigues CMC, Groves H. Community-Acquired Pneumonia in Children: the Challenges of Microbiological Diagnosis. J Clin Microbiol. 2018 Feb 22;56(3):e01318-17. doi: 10.1128/JCM.01318-17. Print 2018 Mar. PMID 29237789
• DiBardino DM, Wunderink RG. Aspiration pneumonia: a review of modern trends. J Crit Care. 2015 Feb;30(1):40-8. doi: 10.1016/j.jcrc.2014.07.011. Epub 2014 Jul 22. PMID 25129577
• Torres A, Niederman MS, Chastre J, Ewig S, Fernandez-Vandellos P, Hanberger H, Kollef M, Li Bassi G, Luna CM, Martin-Loeches I, Paiva JA, Read RC, Rigau D, Timsit JF, Welte T, Wunderink R. International ERS/ESICM/ESCMID/ALAT guidelines for the management of hospital-acquired pneumonia and ventilator-associated pneumonia: Guidelines for the management of hospital-acquired pneumonia (HAP)/ventilator PMID 28890434
• Houck PM, Bratzler DW, Nsa W, Ma A, Bartlett JG. Timing of antibiotic administration and outcomes for Medicare patients hospitalized with community-acquired pneumonia. Arch Intern Med. 2004 Mar 22;164(6):637-44. doi: 10.1001/archinte.164.6.637. PMID 15037492
• Esperatti M, Ferrer M, Theessen A, Liapikou A, Valencia M, Saucedo LM, Zavala E, Welte T, Torres A. Nosocomial pneumonia in the intensive care unit acquired by mechanically ventilated versus nonventilated patients. Am J Respir Crit Care Med. 2010 Dec 15;182(12):1533-9. doi: 10.1164/rccm.201001-0094OC. Epub 2010 Aug 6. PMID 20693381
• Battleman DS, Callahan M, Thaler HT. Rapid antibiotic delivery and appropriate antibiotic selection reduce length of hospital stay of patients with community-acquired pneumonia: link between quality of care and resource utilization. Arch Intern Med. 2002 Mar 25;162(6):682-8. doi: 10.1001/archinte.162.6.682. PMID 11911722
• Jain S, Self WH, Wunderink RG, Fakhran S, Balk R, Bramley AM, Reed C, Grijalva CG, Anderson EJ, Courtney DM, Chappell JD, Qi C, Hart EM, Carroll F, Trabue C, Donnelly HK, Williams DJ, Zhu Y, Arnold SR, Ampofo K, Waterer GW, Levine M, Lindstrom S, Winchell JM, Katz JM, Erdman D, Schneider E, Hicks LA, McCullers JA, Pavia AT, Edwards KM, Finelli L; CDC EPIC Study Team. Community-Acquired Pneumonia R PMID 26172429
• Davidson KR, Ha DM, Schwarz MI, Chan ED. Bronchoalveolar lavage as a diagnostic procedure: a review of known cellular and molecular findings in various lung diseases. J Thorac Dis. 2020 Sep;12(9):4991-5019. doi: 10.21037/jtd-20-651. PMID 33145073

Identifiers

NCT: NCT07626073 · CMUH112-REC1-087

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗