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

NCT05300776 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2022-04-26

No results posted yet for this study

Summary

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

Conditions

Interventions

DIAGNOSTIC_TEST

M-ROSE analysis

The M-ROSE analysis process consists of 3 procudures. 1. 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% . 2. 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. 3. 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.

Sponsors & Collaborators

  • Beijing Chao Yang Hospital

    collaborator OTHER

  • Beijing Anzhen Hospital

    collaborator OTHER

  • Beijing Shijitan Hospital, Capital Medical University

    collaborator OTHER

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Lixin Xie, Ph.D · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05300776 on ClinicalTrials.gov