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

19. april 2022 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Forventet)

166

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Beijing
      • Beijing, Beijing, Kina, 100083
        • Rekruttering
        • Yi Tao
        • Ta kontakt med:
          • Yi Tao
          • Telefonnummer: 17797708263

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

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.
Ingen inngripen: mNGS group
BALF samples were directly sent for mNGS analysis, and anti-infective treatment was guided according to clinical examinations.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
mortality
Tidsramme: During the intervention.
Alive or Dead.
During the intervention.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Blood leukocyte ratio tread
Tidsramme: During the intervention.
The changing of blood leukocyte ratio
During the intervention.
28 day outcome
Tidsramme: 28 days after admission
Live or dead.
28 days after admission
Blood neutriphil ratio tread
Tidsramme: During the intervention.
The changing of blood neutriphil ratio tread
During the intervention.
Blood interleukin 6 tread
Tidsramme: During the intervention.
The changing of blood interleukin 6 tread
During the intervention.
Blood C-reactive protein
Tidsramme: During the intervention.
The changing of blood C-reactive protein
During the intervention.
Blood procalcitonin tread
Tidsramme: During the intervention.
The changing of blood procalcitonin tread
During the intervention.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Lixin Xie, Ph.D, Chinese PLA General Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. mai 2022

Primær fullføring (Forventet)

31. desember 2024

Studiet fullført (Forventet)

31. desember 2024

Datoer for studieregistrering

Først innsendt

8. mars 2022

Først innsendt som oppfylte QC-kriteriene

25. mars 2022

Først lagt ut (Faktiske)

29. mars 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. april 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. april 2022

Sist bekreftet

1. april 2022

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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