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.

Study Overview

• Status: Recruiting
• Conditions: Lung Microbiota

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Gennaro De Pascale, MD; Phone Number: +39 06 30154386; Email: gennaro.depascalemd@gmail.com
• Study Contact Backup: Name: Simone Carelli, MD; Email: simonecarelli.sc@gmail.com

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione Policlinico A. Gemelli IRCCS
    • Contact: Gennaro De Pascale, MD; Email: gennaro.depascalemd@gmail.com
    • Contact: Simone Carelli, MD; Email: simonecarelli.sc@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Gennaro De Pascale, MD, Fondazione Policlinico A. Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 1847

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No