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

• Conditions: Lung Microbiota

• Registration Number: NCT04271345
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Timeline

• Study First Submitted: 2019-02-19
• Study Start: 2019-11-15
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-17
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-03-25
• Primary Completion: 2022-12-31
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of the biodiversity of pulmonary microbioma in a cohort of critically ill ICU patients	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

Secondary Outcome Measures

Name	Time	Method
Clinical cure, defined by the discontinuation (> 72 hours) from mechanical ventilation	36 months	Relate composition and biodiversity of pulmonary microbioma with the occurence and time of clinical cure
Mortality at 28 and 90 days	36 months	Relate composition ad biodiversity of pulmonary microbioma with mortality at 28 and 90 days
Microbiological eradication, defined by a sterile BAL	36 months	Relate composition ad biodiversity of pulmonary microbioma with the occurrence and time of microbiological eradication
Duration of mechanical ventilation, in days	36 months	Relate composition ad biodiversity of pulmonary microbioma with the duration of mechanical ventilation
Duration of cathecolamins administration, in days	36 months	Relate composition ad biodiversity of pulmonary microbioma with the duration of cathecolamins administration
Hospital and ICU lenght of stay, in days	36 months	Relate composition ad biodiversity of pulmonary microbioma with hospital and ICU lenght of stay

Trial Locations

Locations (1)

Fondazione Policlinico A. Gemelli IRCCS; 🇮🇹 Rome, Italy