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

Chinese PLA General Hospital (301 Hospital)

Status: Enrolling

Conditions: Pneumonia

Treatments: Diagnostic Test: M-ROSE analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT05300776

shoufa2022-1-5091

Details and patient eligibility

About

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

Full 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.

Enrollment: 166 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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166 participants in 2 patient groups

M-ROSE combined with mNGS group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: M-ROSE analysis

mNGS group

No Intervention group

Description:

BALF samples were directly sent for mNGS analysis, and anti-infective treatment was guided according to clinical examinations.