Analysis of the Pulmonary Microbiome

Recruiting

• Conditions: Pneumonia; Microbial Disease; Microbial Colonization
• Interventions: Procedure: Bronchoscopy

• Registration Number: NCT06274931
• Lead Sponsor: University Magna Graecia

Brief Summary

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

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 Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-01
• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Primary Completion: 2024-02-20
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23
• Study Completion: 2024-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• pregnancy
• age < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU patients	Bronchoscopy	Patients admitted to the Intensive Care Unit with a diagnosis of acute respiratory failure
non ICU patients	Bronchoscopy	Outpatient patients with a diagnosis of pneumonia

Primary Outcome Measures

Name	Time	Method
Assessment of Lung Microbiome in Acute Respiratory Failure	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.	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.

Trial Locations

Locations (1)

University Hosp[ital; 🇮🇹 Catanzaro, Italy