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RecruitingNCT06274931Updated Feb 23, 2024

Analysis of the Pulmonary Microbiome

An observational study in Pneumonia, Microbial Colonization and Microbial Disease, sponsored by University Magna Graecia. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-23.

Sponsored by University Magna Graecia · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2024, 2 years 8 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Pneumonia
  • Microbial Colonization
  • Microbial Disease
03

In context

Pneumonia

1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.

This study's planned enrollment of 30 is below the median of 252 across 535 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

University Magna Graecia is the lead sponsor of 75 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • age \< 18 years
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • ProcedureBronchoscopy

    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.

06

What researchers measure

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.

    Time frame: 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.

07

Study locations

1 of 1 sites recruiting
  • University Hosp[ital
    Catanzaro, 88100, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2024 (actual). Primary completion is estimated for Feb 2024, 0 months after the start.

Of 210 non-industry observational studies under Pneumonia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 57. This study's planned 0 months is below that.

Counting every sponsor, half of 223 studies reached it within 27 months; a quarter within 13 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2024
First posted
Feb 23, 2024
StartActual
Feb 1, 2024
Primary completionEst.
Feb 20, 2024
CompletionEst.
Jun 20, 2024
Last update
Feb 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06274931
Lead sponsor
University Magna Graecia
Responsible party
Andrea Bruni (Professor, University Magna Graecia) — Principal investigator
First posted
Feb 23, 2024
Start date
Feb 1, 2024
Primary completion
Feb 20, 2024 (estimated)
Completion
Jun 20, 2024 (estimated)
Last update
Feb 23, 2024

Study contacts

Andrea Bruni
Contact
andreabruni@unicz.it
3401414553
Andrea Bruni
principal investigator · Magna Graecia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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