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Lung Microbiota Analysis in Critically Ill Patients Admitted to the Intensive Care Unit.

Analysis of the Pulmonary Microbiota in a Cohort of Critically Ill Patients Admitted to the Intensive Care Unit. Prospective, Observational Trial.

Our study aims to evaluate the relationship between the heterogeneity of pulmonary microbiota and clinical and outcome variables among critically ill patients admitted to the intensive care unit (ICU). In patients undergoing invasive mechanical ventilation, an aliquot of bronchoalveolar lavage (BAL) fluid will be used in the microbiology laboratory for the analysis of respiratory microbiota through next-generation sequencing technologies and validate computational techniques.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

Traditionally, microbiological investigations and clinical trials have contributed to the definition of lower airways as a physiologically sterile district, whose microbiological balance is altered when a respiratory infectious process occur. Actually, the introduction of molecular study methods aiming at the identification of pathogens through genomic sequencing questioned the pardigm of "one bug-one disease", according to which we usually tend to consider a bronchial or pulmonary infectious event as due to the pathogenic role of a single exogenous microorganism. In such a contest, there are truly few data dealing with the characterization of respiratory microbiota in human BAL as well as with the major determinants of this phenomenon and the possible impact on clinical and microbiological outcomes. Our study, although it's a pilot one, aims to evaluate these aspects in a larger cohort of critically ill patients, observing the relationship between the heterogeneity of pulmonary microbiota and clinical and outcome variables. In patients undergoing invasive mechanical ventilation, an aliquot of BAL fluid will be used in the microbiology laboratory for the analysis of respiratory microbiota through next-generation sequencing technologies and validate computational techniques. For each enrolled patient, we will register demographic, clinical and laboratory variables. The benefits deriving from this study lay in the possibility of improving the understanding of characteristics of critical patient's pulmonary microbioma and its clinical impact. Such an information meets the increasingly topical need to customize medical interventions, especially in the context of critically ill patients.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

150

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

All patients admitted to the ICUs and undergoing invasive mechanical ventilation (through oro-tracheal tube or tracheotomy)

Beskrivelse

Inclusion Criteria:

  • execution of bronchoalveolar lavage sampling, either for clinical indications or in the context of surveillance programs
  • acquisition of an informed consent

Exclusion Criteria:

  • presence of significant coagulation abnormalities and/or severe respiratory failure
  • clearly bloody BAL sample
  • small quantity of BAL sample (<5 ml)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Description of the biodiversity of pulmonary microbioma in a cohort of critically ill ICU patients
Tidsramme: 36 months
This aim will be achieved through the use of next-generation sequencing technologies and validate computational techniques, allowing us to taxonomically classify as well as to compare the germs present in BAL samples of ICU patients
36 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical cure, defined by the discontinuation (> 72 hours) from mechanical ventilation
Tidsramme: 36 months
Relate composition and biodiversity of pulmonary microbioma with the occurence and time of clinical cure
36 months
Microbiological eradication, defined by a sterile BAL
Tidsramme: 36 months
Relate composition ad biodiversity of pulmonary microbioma with the occurrence and time of microbiological eradication
36 months
Duration of mechanical ventilation, in days
Tidsramme: 36 months
Relate composition ad biodiversity of pulmonary microbioma with the duration of mechanical ventilation
36 months
Duration of cathecolamins administration, in days
Tidsramme: 36 months
Relate composition ad biodiversity of pulmonary microbioma with the duration of cathecolamins administration
36 months
Hospital and ICU lenght of stay, in days
Tidsramme: 36 months
Relate composition ad biodiversity of pulmonary microbioma with hospital and ICU lenght of stay
36 months
Mortality at 28 and 90 days
Tidsramme: 36 months
Relate composition ad biodiversity of pulmonary microbioma with mortality at 28 and 90 days
36 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Gennaro De Pascale, MD, Fondazione Policlinico A. Gemelli IRCCS

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 (Faktiske)

15. november 2019

Primær færdiggørelse (Forventet)

31. december 2022

Studieafslutning (Forventet)

30. april 2023

Datoer for studieregistrering

Først indsendt

19. februar 2019

Først indsendt, der opfyldte QC-kriterier

13. februar 2020

Først opslået (Faktiske)

17. februar 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1847

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Lung Microbiota

Abonner