NCT05290454: MATESHIP

mNGS -Guided Antimicrobial Treatment in Early Severe Community-Acquired Pneumonia Among Immunocompromised Patients

Status unknown NA Last updated 31 January 2023

What this trial tests

NA trial testing mNGS-guided treatment in Severe Acute Respiratory Infection in 342 participants. Status unknown.

Timeline

19 August 2022

Primary endpoint
1 June 2024

1 September 2024

Quick facts

Lead sponsor	Qilu Hospital of Shandong University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	342
Start date	19 August 2022
Primary completion	1 June 2024
Estimated completion	1 September 2024
Sites	1 location across China

Drugs / interventions tested

• mNGS-guided treatment

Conditions studied

• Severe Acute Respiratory Infection — all drugs for Severe Acute Respiratory Infection →
• Community-acquired Pneumonia — all drugs for Community-acquired Pneumonia →
• Respiratory Tract Infections — all drugs for Respiratory Tract Infections →
• Pneumonia — all drugs for Pneumonia →

Sponsor

Qilu Hospital of Shandong University

Who can join

18 and older, any sex, with Severe Acute Respiratory Infection or Community-acquired Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Metagenomic next-generation sequencing-guided antimicrobial treatment versus conventional antimicrobial treatment in early severe community-acquired pneumonia among immunocompromised patients (MATESHIP): A study protocol.
   Fan S, Si M, Xu N, Yan M, et al · · 2022 · cited 5× · PMID 35983331 · DOI 10.3389/fmicb.2022.927842