Analysis of the Pulmonary Microbiome

The purpose of the protocol is to study the pulmonary microbiome in patients who develop pneumonia.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Microbial Colonization; Microbial Disease
• Intervention / Treatment: Procedure: Bronchoscopy

Detailed Description

The purpose of the protocol is to study the pulmonary microbiome in patients who develop pneumonia with severe acute respiratory failure, requiring admission to the Intensive Care Unit, and to compare it with that of patients diagnosed with pneumonia but who do not develop severe acute respiratory failure and subsequent admission to the intensive care unit.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Andrea Bruni; Phone Number: 3401414553; Email: andreabruni@unicz.it

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • Recruiting
    • University Hosp[ital
    • Contact: Andrea Bruni; Phone Number: 3401414553; Email: andreabruni@unicz.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of three groups: one ICU-patients with a diagnosis acute respiratory failure, another group of non - ICU patients, and finally, a control group of individuals without pulmonary involvement.

Description

Inclusion Criteria:

• Patients with acute respiratory failure
• Patients with suspect of pneumonia

Exclusion Criteria:

• pregnancy
• age < 18 years

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICU patients; Patients admitted to the Intensive Care Unit with a diagnosis of acute respiratory failure	Procedure: Bronchoscopy; Through a bronchoscopic examination performed at the time of admission for diagnostic purposes, an alveolar bronchial lavage was performed for the analysis of the lung microbiome.
non ICU patients; Outpatient patients with a diagnosis of pneumonia	Procedure: Bronchoscopy; Through a bronchoscopic examination performed at the time of admission for diagnostic purposes, an alveolar bronchial lavage was performed for the analysis of the lung microbiome.
Controls; In the control group, an alveolar bronchial lavage was performed directly on lung tissue taken from deceased individuals who did not have any known lung pathologies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Lung Microbiome in Acute Respiratory Failure	This study aims to investigate the composition and diversity of the lung microbiome in patients experiencing acute respiratory failure. Specifically, the research evaluates differences in the lung microbiome between ICU-admitted patients, non-hospitalized individuals, and a control group without known lung pathologies. Through bronchoscopic examinations and alveolar bronchial lavage, the study seeks to elucidate potential associations between lung microbiota and the development of acute respiratory failure. For the analysis of the lung microbiome, the MiSeq Reagent Nano v2 kit is utilized. This kit enables high-throughput sequencing of microbial DNA extracted from samples obtained via bronchoscopic examinations and alveolar bronchial lavage. The MiSeq platform provides accurate and comprehensive data on the microbial composition and diversity present in the lung microbiome of study participants.	The study will be conducted over a period of two months, during which data collection, bronchoscopic examinations, and analysis of the lung microbiome will be carried out.

Collaborators and Investigators

• Sponsor: University Magna Graecia
• Investigators: Principal Investigator: Andrea Bruni, Magna Graecia University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): February 20, 2024
• Study Completion (Estimated): June 20, 2024

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Estimated): February 23, 2024

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 373 (Italian RSO http://osservazionali.agenziafarmaco.it)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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