- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04271345
Lung Microbiota Analysis in Critically Ill Patients Admitted to the Intensive Care Unit.
23. marts 2022 opdateret af: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
- Navn: Gennaro De Pascale, MD
- Telefonnummer: +39 06 30154386
- E-mail: gennaro.depascalemd@gmail.com
Undersøgelse Kontakt Backup
- Navn: Simone Carelli, MD
- E-mail: simonecarelli.sc@gmail.com
Studiesteder
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-
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Rome, Italien, 00168
- Rekruttering
- Fondazione Policlinico A. Gemelli IRCCS
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Kontakt:
- Gennaro De Pascale, MD
- E-mail: gennaro.depascalemd@gmail.com
-
Kontakt:
- Simone Carelli, MD
- E-mail: simonecarelli.sc@gmail.com
-
-
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
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36 months
|
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Duration of cathecolamins administration, in days
Tidsramme: 36 months
|
Relate composition ad biodiversity of pulmonary microbioma with the duration of cathecolamins administration
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36 months
|
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Hospital and ICU lenght of stay, in days
Tidsramme: 36 months
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Relate composition ad biodiversity of pulmonary microbioma with hospital and ICU lenght of stay
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36 months
|
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Mortality at 28 and 90 days
Tidsramme: 36 months
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Relate composition ad biodiversity of pulmonary microbioma with mortality at 28 and 90 days
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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
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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