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Trials
Published in: Trials 1/2023

Open Access 01-12-2023 | Nosocomial Pneumonia | Study protocol

Protocol of a multicenter, single-blind, randomized, parallel controlled trial evaluating the effect of microbiological rapid on-site evaluation (M-ROSE) guiding anti-infection treatment in patients with severe hospital-acquired pneumonia

Authors: Xiuli Wang, Kaifei Wang, Fei Xie, Zhihai Han, Yuhong Liu, Lei Pan, Guangfa Zhu, Zhixin Cao, Peng Yan, Li Xiao, Zhimei Duan, Ye Hu, Kun Xiao, Xuxin Chen, Han Fu, Yinghan Shi, Yuwei Song, Xiaobo Han, Wuxiang Xie, Lixin Xie

Published in: Trials | Issue 1/2023

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Abstract

Introduction

The mortality rate of hospitalized patients with severe hospital-acquired pneumonia (SHAP) remains high. Empirical broad-spectrum antibiotic coverage and the misuse of high-grade antibiotics could lead to the emergence of multi-drug and even pandrug-resistant bacteria. In addition to metagenomic next-generation sequencing (mNGS), microbiological rapid on-site evaluation (M-ROSE) might be a useful technique to identify the pathogens in the early stage; however, the effect of M-ROSE guiding anti-infection treatment on prognostic outcomes of SHAP patients is still unclear.

Methods/design

This is a multicenter, single-blind, prospective, randomized controlled trial to evaluate the effect of M-ROSE guiding anti-infection treatment in SHAP patients, which will provide new strategies for the prevention and control of clinical multi-drug resistance bacteria. A total of 166 patients with SHAP, aged 18 years and over, will be recruited from seven centers in Beijing and randomly assigned to the intervention group (M-ROSE combined with mNGS) or the control group (mNGS only) in a 1:1 ratio using the central randomization system. Patients in the intervention group will accept M-ROSE and mNGS analysis, and the control group will accept mNGS analysis. Individualized anti-infective treatment and routine treatment will be selected according to the analysis results. The primary outcome is the ICU outcome (mortality). The safety of the intervention measures will be evaluated during the entire trial period. This trial will be the first randomized controlled trial to evaluate the effect of M-ROSE guiding treatment on mortality in patients with SHAP and may change the prevalence of multi-drug resistant bacteria.

Ethics and dissemination

This trial adheres to the Declaration of Helsinki and guidelines of Good Clinical Practice. Signed informed consent will be obtained from all participants. The trial has been approved by the Chinese PLA General Hospital (Approval Number: 20220322001).

Trial registration

ClinicalTrials.gov NCT05300776. Registered on 25 March 2022.
Appendix
Available only for authorised users
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Metadata
Title
Protocol of a multicenter, single-blind, randomized, parallel controlled trial evaluating the effect of microbiological rapid on-site evaluation (M-ROSE) guiding anti-infection treatment in patients with severe hospital-acquired pneumonia
Authors
Xiuli Wang
Kaifei Wang
Fei Xie
Zhihai Han
Yuhong Liu
Lei Pan
Guangfa Zhu
Zhixin Cao
Peng Yan
Li Xiao
Zhimei Duan
Ye Hu
Kun Xiao
Xuxin Chen
Han Fu
Yinghan Shi
Yuwei Song
Xiaobo Han
Wuxiang Xie
Lixin Xie
Publication date
01-12-2023
Publisher
BioMed Central
Published in
Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-023-07570-z

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