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

Lung Microbiota Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04271345
• Other study ID #: 1847
• Status: Recruiting
• Start date: November 15, 2019
• Est. completion date: April 30, 2023

Study information

• Verified date: March 2022
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Gennaro De Pascale, MD
• Phone: +39 06 30154386
• Email: gennaro.depascalemd[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Lung Microbiota

Locations

Country	Name	City	State
Italy	Fondazione Policlinico A. Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	36 months
Secondary	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	36 months
Secondary	Microbiological eradication, defined by a sterile BAL	Relate composition ad biodiversity of pulmonary microbioma with the occurrence and time of microbiological eradication	36 months
Secondary	Duration of mechanical ventilation, in days	Relate composition ad biodiversity of pulmonary microbioma with the duration of mechanical ventilation	36 months
Secondary	Duration of cathecolamins administration, in days	Relate composition ad biodiversity of pulmonary microbioma with the duration of cathecolamins administration	36 months
Secondary	Hospital and ICU lenght of stay, in days	Relate composition ad biodiversity of pulmonary microbioma with hospital and ICU lenght of stay	36 months
Secondary	Mortality at 28 and 90 days	Relate composition ad biodiversity of pulmonary microbioma with mortality at 28 and 90 days	36 months