M-ROSE Combined With mNGS in Severe Hospital-acquired Pneumonia

A Multi-center Prospective Clinical Study of M-ROSE Combined With mNGS to Guide the Individualized Anti-infection Treatment, Prevention and Control of Drug-resistant Bacteria in Severe Hospital-acquired Pneumonia

The purpose of this study is to determine the value of M-ROSE（microbiological rapid on-site evaluation）in severe hospital-acquired pneumonia.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia
• Intervention / Treatment: Diagnostic test: M-ROSE analysis

Detailed Description

Severe hospital acquired pneumonia (SHAP) is the critical risk factor leading to the death of nosocomial infection patients. Rapid identification of pathogens, guidance of individualized treatment and rational application of antibiotics can not only improve the administration of antibiotics, but also reduce the production of multi drug resistant bacteria. Metagenomic second-generation sequencing (mNGS) is an important tool to quickly identify the pathogen in ICU. However, due to the low qualified rate of lower respiratory tract specimens in patients with SHAP, easily polluted, and the difficulty to determine whether microorganisms are infectious, colonizated or polluted, the value of mNGS was limited in the etiological diagnosis of SHAP. The bedside M-ROSE system established by our research team can determine whether the lower respiratory tract specimen is qualified, whether infection exists and the pathogen of infection within half an hour. Based on the previous work, this project plans to conduct a prospective multicenter, single blind, randomized controlled study under the guidance of M-ROSE and mNGS in the individualized anti-infection strategy of SHAP, to reduce the mortality of patients with SHAP; Combined with the third-generation sequencing, the standard analysis framework for the traceability and prevention and control of drug-resistant bacteria was established to clarify the transmission route of drug-resistant bacteria, so as to provide a new solution for the prevention and control of clinical multidrug-resistant bacteria.

• Study Type: Interventional
• Enrollment (Anticipated): 166
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Tao, Ph.D; Phone Number: +8617797708263; Email: taoyimmu@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100083
      • Recruiting
      • Yi Tao
      • Contact: Yi Tao; Phone Number: 17797708263

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of severe hospital-acquired pneumonia
• Must have undergone bronchoalveolar lavage

Exclusion Criteria:

• BALF samples were not sent for mNGS examination
• Age < 18 years old
• The hospitalization days ≤ 3
• The clinical data are incomplete
• Mechanical ventilation time > 60 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: M-ROSE combined with mNGS group; The bronchoalveolar lavage fluid (BALF) of patients undergoes M-ROSE analysis and decide whether the samples are qualified, whether they indicate bacterial infection and identify pathogens, and the qualified samples are sent for mNGS analysis. The individualized anti-infection treatment is comprehensively guided according to the results of M-ROSE, mNGS and clinical examinations.	Diagnostic test: M-ROSE analysis; The M-ROSE analysis process consists of 3 procudures.; Specimen quality assessment. The BALF undergoes the process of smear, diff-quik stain, gram stain and are analyzed by experts to report the cytoloy and pathogen patterns to determine whether the sample is qualified according to the cell proportions. The qualified BALF samples are: squamous epithelial cell proportion<1%, columnar epithelial cell proportion <5% .; Distinguish infection and colonization. According to the cytoloy pattern, the proportion of neutrophils > 50% often strongly suggests pulmonary bacterial infection; Neutrophil phagocytosis proportion> 5% indicates infection, and phagocytosis of bacteria is the pathogen. Besides, fungal and hyphae can be found under the microscope.; Preliminary identification of infectious pathogens. Identify the infected bacteria and fungi, and the results are gram-positive cocci, gram-positive bacilli, gram-negative cocci, gram-negative bacilli, yeasts and molds.
No Intervention: mNGS group; BALF samples were directly sent for mNGS analysis, and anti-infective treatment was guided according to clinical examinations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	Alive or Dead.	During the intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood leukocyte ratio tread	The changing of blood leukocyte ratio	During the intervention.
28 day outcome	Live or dead.	28 days after admission
Blood neutriphil ratio tread	The changing of blood neutriphil ratio tread	During the intervention.
Blood interleukin 6 tread	The changing of blood interleukin 6 tread	During the intervention.
Blood C-reactive protein	The changing of blood C-reactive protein	During the intervention.
Blood procalcitonin tread	The changing of blood procalcitonin tread	During the intervention.

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Beijing Chao Yang Hospital; Beijing Shijitan Hospital, Capital Medical University; Beijing Anzhen Hospital
• Investigators: Principal Investigator: Lixin Xie, Ph.D, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: treatment; mNGS; M-ROSE; severe hospital-acquired pneumonia
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia
• Other Study ID Numbers: shoufa2022-1-5091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No