Ignite Creation Date:
2024-05-06 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05290454
Status:
RECRUITING
Last Update Posted:
2023-01-31
First Post:
2022-03-03
Brief Title:
mNGS -Guided Antimicrobial Treatment in Early Severe Community-Acquired Pneumonia Among Immunocompromised Patients
Sponsor:
Qilu Hospital of Shandong University
Organization:
Qilu Hospital of Shandong University
Study Overview
Official Title:
mNGS -Guided Antimicrobial Treatment Versus Conventional Antimicrobial Treatment in Early Severe Community-Acquired Pneumonia Among Immunocompromised Patients
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MATESHIP
Brief Summary:
Severe Community-acquired pneumonia SCAP is a leading global infectious cause of intensive care unit ICU admission approximately 20-30 and the primary reason of mortality and morbidity in immunocompromised patients There is a global increase of patients with distinct immunocompromised conditions due to the advance of cancer treatment increasing biologics and immunosuppressants for autoimmune diseases and growing organ transplant recipients and it has been estimated that patients with immunocompromised conditions account for approximately 35 of all intensive care unit ICU admissions Immunocompromised patients with SCAP have more factors to complicate with sepsis respiratory failure acute respiratory distress syndrome and the mortality rate can be up to 50 With the aim to apply early accurate antimicrobial therapy to improve clinical prognosis of SCAP patients with immunocompromised conditions timely identification of pathogen is particularly important Conventional microbiological diagnostic methods such as standard microbiologic cultures microscopy polymerase chain reaction PCR respiratory virus multiplex PCR as well as pathogen-specific antigens and antibody assays are currently commonly used to detect pathogens although they have various limitations However conventional antimicrobial therapy depends on the results of conventional diagnostic methods which may delay timely accurate antimicrobial therapy at the initial stage and the mortality of immunocompromised patients with SCAP may be increased Metagenomic next-generation sequencing mNGS which can determine pathogens more quickly usually within 24h and accurately comparing with conventional diagnostic methods by analyzing cell-free nucleic acid fragments of pathogens using appropriate lower respiratory tract LRT specimen is increasingly used in severe respiratory infectious disease especially among immunocompromised patients This study aims to determine whether mNGS using LRT specimen guided antimicrobial treatment improves clinical prognosis of SCAP patients with immunocompromised conditions when compared with conventional antimicrobial treatment
Detailed Description:
Severe Community-acquired pneumonia SCAP is an emergence infection disease of lung parenchyma that acquired outside of a hospital setting SCAP is a leading global infectious cause of intensive care unit ICU admission approximately 20-30 and the primary reason of mortality and morbidity in immunocompromised patients There is a global increase of patients with distinct immunocompromised conditions due to the advance of cancer treatment increasing biologics and immunosuppressants for autoimmune diseases and growing organ transplant recipients and it has been estimated that patients with immunocompromised conditions account for approximately 35 of all intensive care unit ICU admissions Immunocompromised patients who always at risk of mixed and unusual pathogens infection have more factors to complicate with sepsis respiratory failure acute respiratory distress syndrome and the mortality rate can be up to 50 Moreover the outcomes in immunocompromised patients with SCAP not only related to disease severity but also related to delays initiation of receiving appropriate therapy 2019American Thoracic Society ATSInfectious Diseases Society of America IDSA community-acquired pneumonia CAP guideline recommends that administering appropriate antimicrobials as soon as possible is the most effective measure to improve clinical prognosis and reduce mortality rate for SCAP patients Therefore timely identification of pathogenic microorganisms is particularly crucial for antimicrobial treatment in immunocompromised patients with SCAP
Conventional microbiology diagnostic methods such as standard microbiologic cultures microscopy polymerase chain reaction PCR respiratory virus multiplex PCR as well as pathogen-specific antigens and antibody assays are associated with relevant limitations 1 long culture cycle and low positive rate 2 usually only one pathogen can be detected at a time 3 inability to detect fastidious or difficult culture organisms 4 pathogen antibody-based testing may be unreliable in immunocompromised patients who are unable to mount antibody responses Conventional diagnostic methods make big challenge for pathogens diagnosis of SCAP among immunocompromised patients due to above limitations and the complicated causative microorganisms However conventional antimicrobial therapy based on the results of conventional microbiology diagnostic techniques which may delay timely accurate antimicrobial therapy at the initial stage and the mortality of immunocompromised patients with SCAP may be increased Metagenomic next-generation sequencing mNGS which can quickly usually within 24h detect a wide array of bacteria viruses and fungi in an unbiased manner at the same time by analyzing cell-free nucleic acid DNA fragments of pathogens using appropriate lower respiratory tract LRT specimen is increasingly used in severe infectious disease especially among immunocompromised patients This study speculates that mNGS using LRT specimen can guide early and accurate antimicrobial treatment for immunocompromised patients with SCAP This multi-center opening randomized controlled trail will enroll SCAP patients with immunocompromised conditions to determine whether mNGS-guided antimicrobial treatment improve the clinical prognosis and increase the clinical cure rate The purpose of this study is to characterize the effect of mNGS-guided antimicrobial treatment for SCAP versus conventional treatment among immunocompromised patients It is postulated that mNGS-guided antimicrobial treatment for immunocompromised patients with SCAP will improve clinical outcomes among these patients
Conventional microbiology diagnostic methods such as standard microbiologic cultures microscopy polymerase chain reaction PCR respiratory virus multiplex PCR as well as pathogen-specific antigens and antibody assays are associated with relevant limitations 1 long culture cycle and low positive rate 2 usually only one pathogen can be detected at a time 3 inability to detect fastidious or difficult culture organisms 4 pathogen antibody-based testing may be unreliable in immunocompromised patients who are unable to mount antibody responses Conventional diagnostic methods make big challenge for pathogens diagnosis of SCAP among immunocompromised patients due to above limitations and the complicated causative microorganisms However conventional antimicrobial therapy based on the results of conventional microbiology diagnostic techniques which may delay timely accurate antimicrobial therapy at the initial stage and the mortality of immunocompromised patients with SCAP may be increased Metagenomic next-generation sequencing mNGS which can quickly usually within 24h detect a wide array of bacteria viruses and fungi in an unbiased manner at the same time by analyzing cell-free nucleic acid DNA fragments of pathogens using appropriate lower respiratory tract LRT specimen is increasingly used in severe infectious disease especially among immunocompromised patients This study speculates that mNGS using LRT specimen can guide early and accurate antimicrobial treatment for immunocompromised patients with SCAP This multi-center opening randomized controlled trail will enroll SCAP patients with immunocompromised conditions to determine whether mNGS-guided antimicrobial treatment improve the clinical prognosis and increase the clinical cure rate The purpose of this study is to characterize the effect of mNGS-guided antimicrobial treatment for SCAP versus conventional treatment among immunocompromised patients It is postulated that mNGS-guided antimicrobial treatment for immunocompromised patients with SCAP will improve clinical outcomes among these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None