An observational study in Lung Microbiota, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-25.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
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.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 948 studies on the registry; 537 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients admitted to the ICUs and undergoing invasive mechanical ventilation (through oro-tracheal tube or tracheotomy)
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Description of the biodiversity of pulmonary microbioma in a cohort of critically ill ICU patients
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
Time frame: 36 months
Clinical cure, defined by the discontinuation (> 72 hours) from mechanical ventilation
Relate composition and biodiversity of pulmonary microbioma with the occurence and time of clinical cure
Time frame: 36 months
Microbiological eradication, defined by a sterile BAL
Relate composition ad biodiversity of pulmonary microbioma with the occurrence and time of microbiological eradication
Time frame: 36 months
Duration of mechanical ventilation, in days
Relate composition ad biodiversity of pulmonary microbioma with the duration of mechanical ventilation
Time frame: 36 months
Duration of cathecolamins administration, in days
Relate composition ad biodiversity of pulmonary microbioma with the duration of cathecolamins administration
Time frame: 36 months
Hospital and ICU lenght of stay, in days
Relate composition ad biodiversity of pulmonary microbioma with hospital and ICU lenght of stay
Time frame: 36 months
Mortality at 28 and 90 days
Relate composition ad biodiversity of pulmonary microbioma with mortality at 28 and 90 days
Time frame: 36 months
Started Nov 2019 (actual). Primary completion is estimated for Dec 2022, 37 months after the start.
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This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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