Lung MicrobiotaNCT04271345
Lung Microbiota Analysis in Critically Ill Patients Admitted to the Intensive Care Unit.
An observational study of Lung Microbiota, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Our study aims to evaluate the relationship between the heterogeneity of pulmonary microbiota and clinical and outcome variables among critically ill patients admitted to the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Microbiota
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2019to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to the ICUs and undergoing invasive mechanical ventilation (through oro-tracheal tube or tracheotomy)
Who may be able to join
- execution of bronchoalveolar lavage sampling, either for clinical indications or in the context of surveillance programs
- acquisition of an informed consent
Who cannot join
- presence of significant coagulation abnormalities and/or severe respiratory failure
- clearly bloody BAL sample
- small quantity of BAL sample (<5 ml)
Trial locations and contacts
1 site in 1 country.
Simone Carelli, MD contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico A. Gemelli IRCCS
Rome, 00168
Gennaro De Pascale, MD, gennaro.depascalemd@gmail.com
Simone Carelli, MD, simonecarelli.sc@gmail.com
About this study
Official title: Analysis of the Pulmonary Microbiota in a Cohort of Critically Ill Patients Admitted to the Intensive Care Unit. Prospective, Observational Trial.
Our study aims to evaluate the relationship between the heterogeneity of pulmonary microbiota and clinical and outcome variables among critically ill patients admitted to the intensive care unit (ICU). In patients undergoing invasive mechanical ventilation, an aliquot of bronchoalveolar lavage (BAL) fluid will be used in the microbiology laboratory for the analysis of respiratory microbiota through next-generation sequencing technologies and validate computational techniques.
Read the detailed description
Traditionally, microbiological investigations and clinical trials have contributed to the definition of lower airways as a physiologically sterile district, whose microbiological balance is altered when a respiratory infectious process occur. Actually, the introduction of molecular study methods aiming at the identification of pathogens through genomic sequencing questioned the pardigm of "one bug-one disease", according to which we usually tend to consider a bronchial or pulmonary infectious event as due to the pathogenic role of a single exogenous microorganism. In such a contest, there are truly few data dealing with the characterization of respiratory microbiota in human BAL as well as with the major determinants of this phenomenon and the possible impact on clinical and microbiological outcomes. Our study, although it's a pilot one, aims to evaluate these aspects in a larger cohort of critically ill patients, observing the relationship between the heterogeneity of pulmonary microbiota and clinical and outcome variables. In patients undergoing invasive mechanical ventilation, an aliquot of BAL fluid will be used in the microbiology laboratory for the analysis of respiratory microbiota through next-generation sequencing technologies and validate computational techniques. For each enrolled patient, we will register demographic, clinical and laboratory variables. The benefits deriving from this study lay in the possibility of improving the understanding of characteristics of critical patient's pulmonary microbioma and its clinical impact. Such an information meets the increasingly topical need to customize medical interventions, especially in the context of critically ill patients.
- Conditions
- Lung Microbiota
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the biodiversity of pulmonary microbioma in a cohort of critically ill ICU patients
This aim will be achieved through the use of next-generation sequencing technologies and validate computational techniques, allowing us to taxonomically classify as well as to compare the germs present in BAL samples of ICU patients
Measured: 36 months
Secondary outcomes (6)
Clinical cure, defined by the discontinuation (> 72 hours) from mechanical ventilation
Relate composition and biodiversity of pulmonary microbioma with the occurence and time of clinical cure
Measured: 36 months
Microbiological eradication, defined by a sterile BAL
Relate composition ad biodiversity of pulmonary microbioma with the occurrence and time of microbiological eradication
Measured: 36 months
Duration of mechanical ventilation, in days
Relate composition ad biodiversity of pulmonary microbioma with the duration of mechanical ventilation
Measured: 36 months
Duration of cathecolamins administration, in days
Relate composition ad biodiversity of pulmonary microbioma with the duration of cathecolamins administration
Measured: 36 months
Hospital and ICU lenght of stay, in days
Relate composition ad biodiversity of pulmonary microbioma with hospital and ICU lenght of stay
Measured: 36 months
Mortality at 28 and 90 days
Relate composition ad biodiversity of pulmonary microbioma with mortality at 28 and 90 days
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start15 Nov 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung MicrobiotaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gennaro De Pascale, MD, Principal investigator, Fondazione Policlinico A. Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271345
- Sponsor's protocol ID
- 1847
- Status last verified
- Mar 2022
- First submitted
- 19 Feb 2019
- Last updated
- 25 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Pascale G, Posteraro B, De Maio F, Pafundi PC, Tanzarella ES, Cutuli SL, Lombardi G, Grieco DL, Franchini E, Santarelli G, Infante A, Sanguinetti M, Antonelli M. Lung microbiota composition, respiratory mechanics, and outcomes in COVID-19-related ARDS. Microbiol Spectr. 2024 Apr 2;12(4):e0357423. doi: 10.1128/spectrum.03574-23. Epub 2024 Mar 11.
PubMed 38466118
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Pulmonary Microbiota in a Cohort of Critically Ill Patients Admitted to the Intensive Care Unit. Prospective, Observational Trial.
- ClinicalTrials.gov ID
- NCT04271345
- Acronym / sponsor ID
- 1847
- Conditions
- Lung Microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study aims to evaluate the relationship between the heterogeneity of pulmonary microbiota and clinical and outcome variables among critically ill patients admitted to the intensive care unit (ICU). In patients undergoing invasive mechanical ventilation, an aliquot of bronchoalveolar lavage (BAL) fluid will be used in the microbiology laboratory for the analysis of respiratory microbiota through next-generation sequencing technologies and validate computational techniques.
Detailed description
Traditionally, microbiological investigations and clinical trials have contributed to the definition of lower airways as a physiologically sterile district, whose microbiological balance is altered when a respiratory infectious process occur. Actually, the introduction of molecular study methods aiming at the identification of pathogens through genomic sequencing questioned the pardigm of "one bug-one disease", according to which we usually tend to consider a bronchial or pulmonary infectious event as due to the pathogenic role of a single exogenous microorganism. In such a contest, there are truly few data dealing with the characterization of respiratory microbiota in human BAL as well as with the major determinants of this phenomenon and the possible impact on clinical and microbiological outcomes. Our study, although it's a pilot one, aims to evaluate these aspects in a larger cohort of critically ill patients, observing the relationship between the heterogeneity of pulmonary microbiota and clinical and outcome variables. In patients undergoing invasive mechanical ventilation, an aliquot of BAL fluid will be used in the microbiology laboratory for the analysis of respiratory microbiota through next-generation sequencing technologies and validate computational techniques. For each enrolled patient, we will register demographic, clinical and laboratory variables. The benefits deriving from this study lay in the possibility of improving the understanding of characteristics of critical patient's pulmonary microbioma and its clinical impact. Such an information meets the increasingly topical need to customize medical interventions, especially in the context of critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the ICUs and undergoing invasive mechanical ventilation (through oro-tracheal tube or tracheotomy)
Key inclusion criteria (2 listed)
- execution of bronchoalveolar lavage sampling, either for clinical indications or in the context of surveillance programs
- acquisition of an informed consent
Key exclusion criteria (3 listed)
- presence of significant coagulation abnormalities and/or severe respiratory failure
- clearly bloody BAL sample
- small quantity of BAL sample (<5 ml)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of the biodiversity of pulmonary microbioma in a cohort of critically ill ICU patients
Time frame: 36 months
This aim will be achieved through the use of next-generation sequencing technologies and validate computational techniques, allowing us to taxonomically classify as well as to compare the germs present in BAL samples of ICU patients
6 secondary outcomes
Clinical cure, defined by the discontinuation (> 72 hours) from mechanical ventilation
Time frame: 36 months
Microbiological eradication, defined by a sterile BAL
Time frame: 36 months
Duration of mechanical ventilation, in days
Time frame: 36 months
Duration of cathecolamins administration, in days
Time frame: 36 months
Hospital and ICU lenght of stay, in days
Time frame: 36 months
Mortality at 28 and 90 days
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Derived from this study: PubMed 38466118De Pascale G, Posteraro B, De Maio F, Pafundi PC, Tanzarella ES, Cutuli SL, Lombardi G, Grieco DL, Franchini E, Santarelli G, Infante A, Sanguinetti M, Antonelli M. Lung microbiota composition, respiratory mechanics, and outcomes in COVID-19-related ARDS. Microbiol Spectr. 2024 Apr 2;12(4):e0357423. doi: 10.1128/spectrum.03574-23. Epub 2024 Mar 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Carelli, MD contact
Gennaro De Pascale, MD principal investigator
Fondazione Policlinico A. Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Microbiota, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gennaro De Pascale, MD (+39 06 30154386, gennaro.depascalemd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the biodiversity of pulmonary microbioma in a cohort of critically ill ICU patients (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04271345, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.