Analysis of the Pulmonary Microbiome

NCT06274931 | Recruiting

• 1 other identifier: 373
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pneumonia; Microbial Colonization; Microbial Disease

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

ICU patients

Patients admitted to the Intensive Care Unit with a diagnosis of acute respiratory failure

Procedure: Bronchoscopy

non ICU patients

Outpatient patients with a diagnosis of pneumonia

Procedure: Bronchoscopy

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.

Interventions

Bronchoscopy PROCEDURE

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.

ICU patients; non ICU patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• pregnancy
• age \< 18 years

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

University Hosp[ital

Catanzaro, 88100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

bronchoalveolar lavage (BAL)

MeSH Terms

Conditions

Pneumonia; Communicable Diseases

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Andrea Bruni

  Magna Graecia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Bruni

CONTACT

3401414553; andreabruni@unicz.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 23, 2024
• Study Start: February 1, 2024
• Primary Completion: February 20, 2024
• Study Completion: June 20, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)