Clinical trial NCT04271345: Lung Microbiota Analysis in Critically Ill Patients Admitted to the Intensive Care Unit.
Official title: Analysis of the Pulmonary Microbiota in a Cohort of Critically Ill Patients Admitted to the Intensive Care Unit. Prospective, Observational Trial.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Microbiota
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the ICUs and undergoing invasive mechanical ventilation (through oro-tracheal tube or tracheotomy)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Description of the biodiversity of pulmonary microbioma in a cohort of critically ill ICU patients
timeFrame: 36 months
Secondary outcomes:
measure: Clinical cure, defined by the discontinuation (> 72 hours) from mechanical ventilation
timeFrame: 36 months
measure: Microbiological eradication, defined by a sterile BAL
timeFrame: 36 months
measure: Duration of mechanical ventilation, in days
timeFrame: 36 months
measure: Duration of cathecolamins administration, in days
timeFrame: 36 months
measure: Hospital and ICU lenght of stay, in days
timeFrame: 36 months
measure: Mortality at 28 and 90 days
timeFrame: 36 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico A. Gemelli IRCCS
name: Gennaro De Pascale, MD
role: PRINCIPAL_INVESTIGATOR
References: