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NCT06274931 Clinical Trial

Analysis of the Pulmonary Microbiome

Pneumonia Clinical Trial

Official title:
Analysis of the Pulmonary Microbiome

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06274931
Other study ID # 373
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2024
Est. completion date June 20, 2024

Study information
Verified date February 2024
Source University Magna Graecia
Contact Andrea Bruni
Phone 3401414553
Email andreabruni@unicz.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date June 20, 2024
Est. primary completion date February 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with acute respiratory failure - Patients with suspect of pneumonia Exclusion Criteria: - pregnancy - age < 18 years

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Italy University Hosp[ital Catanzaro

Sponsors (1)
Lead Sponsor Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
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