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| Name | Class |
|---|---|
| Beijing Chao Yang Hospital | OTHER |
| Beijing Anzhen Hospital | OTHER |
| Beijing Shijitan Hospital, Capital Medical University | OTHER |
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The purpose of this study is to determine the value of M-ROSE(microbiological rapid on-site evaluation)in severe hospital-acquired pneumonia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M-ROSE combined with mNGS group | Experimental | 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. |
|
| mNGS group | No Intervention | BALF samples were directly sent for mNGS analysis, and anti-infective treatment was guided according to clinical examinations. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M-ROSE analysis | Diagnostic Test | The M-ROSE analysis process consists of 3 procudures.
|
| Measure | Description | Time Frame |
|---|---|---|
| mortality | Alive or Dead. | During the intervention. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Tao, Ph.D | Contact | +8617797708263 | taoyimmu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lixin Xie, Ph.D | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yi Tao | Recruiting | Beijing | Beijing Municipality | 100083 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37612723 | Derived | Wang X, Wang K, Xie F, Han Z, Liu Y, Pan L, Zhu G, Cao Z, Yan P, Xiao L, Duan Z, Hu Y, Xiao K, Chen X, Fu H, Shi Y, Song Y, Han X, Xie W, Xie L. 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. Trials. 2023 Aug 23;24(1):552. doi: 10.1186/s13063-023-07570-z. |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D000077299 | Healthcare-Associated Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| 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. |
| D003428 |
| Cross Infection |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |