Exploratory Analysis of Pulmonary Microbiome in Intubated Patients

NCT03720093 | Completed

• 1 other identifier: Microbiota Polmonare in ICU
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 3

Brief Summary

This prospective, multicentric study investigates the modifications of pulmonary microbiome that occur in patients who need mechanical ventilation for non-pulmonary conditions. Genomic analysis will be performed by 16S RNA amplification on biological samples (bronchial aspirate) collected from patients.

Conditions

Intubation Complication

Keywords

ventilation; intubation; pulmonary microbiome

Outcome Measures

Primary Outcomes (1)

• Changes of pulmonary microbiome between the time of intubation and 72 hours post-intubation, through genetic analysis of bacterial 16 Svedberg (16S) ribosomal RNA in bronchial aspirate.

  Two samples of bronchial aspirate were collected (one at the time of incubation and one 72 hours post-intubation) and analyzed by Polymerase Chain Reaction (PCR) by amplifying 16 Svedberg (16S) ribosomal RNA. Primers that specifically recognize hypervariable regions of 16S sub-unit will be used. At 5' end an adaptor will be inserted to prepare the MiSeqsequencing library. The classification of microbiome taxa will be expressed as diversity measure (diversity index alpha or beta); the frequency of the most represented taxa and the confidence interval will be calculated. Differences in microbiome composition will be represented with the analysis of principal coordinates (PCoA) based on phylogenetic distance (matrix UNIFRAC).

  At the time of intubation and after 72 hours from intubation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intubated patients with mechanical ventilation for at least 48 hours

You may qualify if:

• patients undergo mechanical ventilation for non-pulmonary conditions (i.e. neurological condition)
• patients who are expected to need mechanical ventilation for \>48 hours

You may not qualify if:

• diagnosis at the ICU admission of pneumonia
• need of mechanical ventilation for pulmonary conditions.

Sponsors & Collaborators

• University of Milano Bicocca: lead
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator
• Niguarda Hospital: collaborator
• Parma University Hospital: collaborator

Study Sites (3)

ASST-Monza

Monza, MB, 20900, Italy

Location

Ospedale Niguarda

Milan, 20121, Italy

Location

Ospedale di Parma

Parma, 43126, Italy

Location

Related Publications (8)

• McDonald D, Ackermann G, Khailova L, Baird C, Heyland D, Kozar R, Lemieux M, Derenski K, King J, Vis-Kampen C, Knight R, Wischmeyer PE. Extreme Dysbiosis of the Microbiome in Critical Illness. mSphere. 2016 Aug 31;1(4):e00199-16. doi: 10.1128/mSphere.00199-16. eCollection 2016 Jul-Aug.

  PMID: 27602409 BACKGROUND

• Zaborin A, Smith D, Garfield K, Quensen J, Shakhsheer B, Kade M, Tirrell M, Tiedje J, Gilbert JA, Zaborina O, Alverdy JC. Membership and behavior of ultra-low-diversity pathogen communities present in the gut of humans during prolonged critical illness. mBio. 2014 Sep 23;5(5):e01361-14. doi: 10.1128/mBio.01361-14.

  PMID: 25249279 BACKGROUND

• Ojima M, Motooka D, Shimizu K, Gotoh K, Shintani A, Yoshiya K, Nakamura S, Ogura H, Iida T, Shimazu T. Metagenomic Analysis Reveals Dynamic Changes of Whole Gut Microbiota in the Acute Phase of Intensive Care Unit Patients. Dig Dis Sci. 2016 Jun;61(6):1628-34. doi: 10.1007/s10620-015-4011-3. Epub 2015 Dec 29.

  PMID: 26715502 BACKGROUND

• Charlson ES, Bittinger K, Haas AR, Fitzgerald AS, Frank I, Yadav A, Bushman FD, Collman RG. Topographical continuity of bacterial populations in the healthy human respiratory tract. Am J Respir Crit Care Med. 2011 Oct 15;184(8):957-63. doi: 10.1164/rccm.201104-0655OC. Epub 2011 Jun 16.

  PMID: 21680950 BACKGROUND

• Morris A, Beck JM, Schloss PD, Campbell TB, Crothers K, Curtis JL, Flores SC, Fontenot AP, Ghedin E, Huang L, Jablonski K, Kleerup E, Lynch SV, Sodergren E, Twigg H, Young VB, Bassis CM, Venkataraman A, Schmidt TM, Weinstock GM; Lung HIV Microbiome Project. Comparison of the respiratory microbiome in healthy nonsmokers and smokers. Am J Respir Crit Care Med. 2013 May 15;187(10):1067-75. doi: 10.1164/rccm.201210-1913OC.

  PMID: 23491408 BACKGROUND

• Segal LN, Alekseyenko AV, Clemente JC, Kulkarni R, Wu B, Gao Z, Chen H, Berger KI, Goldring RM, Rom WN, Blaser MJ, Weiden MD. Enrichment of lung microbiome with supraglottic taxa is associated with increased pulmonary inflammation. Microbiome. 2013 Jul 1;1(1):19. doi: 10.1186/2049-2618-1-19.

  PMID: 24450871 BACKGROUND

• Segal LN, Rom WN, Weiden MD. Lung microbiome for clinicians. New discoveries about bugs in healthy and diseased lungs. Ann Am Thorac Soc. 2014 Jan;11(1):108-16. doi: 10.1513/AnnalsATS.201310-339FR.

  PMID: 24460444 BACKGROUND

• Berdal JE, Bjornholt J, Blomfeldt A, Smith-Erichsen N, Bukholm G. Patterns and dynamics of airway colonisation in mechanically-ventilated patients. Clin Microbiol Infect. 2007 May;13(5):476-80. doi: 10.1111/j.1469-0691.2006.01678.x.

  PMID: 17430338 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Bronchial aspirate

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Citerio, Professor

  University of Milano Bicocca

  STUDY DIRECTOR

• Andrea Gori, Professor

  Fondazione Cà Granda, Policlinico Milano

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 25, 2018
• Study Start: October 8, 2017
• Primary Completion: November 20, 2019
• Study Completion: January 24, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)