- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05300776
M-ROSE Combined With mNGS in Severe Hospital-acquired Pneumonia
19. april 2022 opdateret af: wang kaifei, Chinese PLA General Hospital
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
The purpose of this study is to determine the value of M-ROSE(microbiological rapid on-site evaluation)in severe hospital-acquired pneumonia.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
166
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yi Tao, Ph.D
- Telefonnummer: +8617797708263
- E-mail: taoyimmu@163.com
Studiesteder
-
-
Beijing
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Beijing, Beijing, Kina, 100083
- Rekruttering
- Yi Tao
-
Kontakt:
- Yi Tao
- Telefonnummer: 17797708263
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: M-ROSE combined with mNGS group
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.
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The M-ROSE analysis process consists of 3 procudures.
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Ingen indgriben: mNGS group
BALF samples were directly sent for mNGS analysis, and anti-infective treatment was guided according to clinical examinations.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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mortality
Tidsramme: During the intervention.
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Alive or Dead.
|
During the intervention.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood leukocyte ratio tread
Tidsramme: During the intervention.
|
The changing of blood leukocyte ratio
|
During the intervention.
|
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28 day outcome
Tidsramme: 28 days after admission
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Live or dead.
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28 days after admission
|
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Blood neutriphil ratio tread
Tidsramme: During the intervention.
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The changing of blood neutriphil ratio tread
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During the intervention.
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Blood interleukin 6 tread
Tidsramme: During the intervention.
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The changing of blood interleukin 6 tread
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During the intervention.
|
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Blood C-reactive protein
Tidsramme: During the intervention.
|
The changing of blood C-reactive protein
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During the intervention.
|
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Blood procalcitonin tread
Tidsramme: During the intervention.
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The changing of blood procalcitonin tread
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During the intervention.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Lixin Xie, Ph.D, Chinese PLA General Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. maj 2022
Primær færdiggørelse (Forventet)
31. december 2024
Studieafslutning (Forventet)
31. december 2024
Datoer for studieregistrering
Først indsendt
8. marts 2022
Først indsendt, der opfyldte QC-kriterier
25. marts 2022
Først opslået (Faktiske)
29. marts 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. april 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. april 2022
Sidst verificeret
1. april 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- shoufa2022-1-5091
Plan for individuelle deltagerdata (IPD)
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