Clinical trial NCT05300776: M-ROSE Combined With mNGS in Severe Hospital-acquired Pneumonia
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pneumonia
Keywords: M-ROSE
mNGS
severe hospital-acquired pneumonia
treatment
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Chao Yang Hospital
name: Beijing Anzhen Hospital
name: Beijing Shijitan Hospital, Capital Medical University
First posted: 2022-03-29
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: mortality
timeFrame: During the intervention.
Secondary outcomes:
measure: Blood leukocyte ratio tread
timeFrame: During the intervention.
measure: 28 day outcome
timeFrame: 28 days after admission
measure: Blood neutriphil ratio tread
timeFrame: During the intervention.
measure: Blood interleukin 6 tread
timeFrame: During the intervention.
measure: Blood C-reactive protein
timeFrame: During the intervention.
measure: Blood procalcitonin tread
timeFrame: During the intervention.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yi Tao
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Lixin Xie, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: