PneumoniaENIRRIsNCT03183921
Study on ICU Patients With Nosocomial Lower Respiratory Tract Infections
An observational study of Pneumonia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Ireland.
Trial summary
This is a multicentre, multinational, prospective observational investigation on ICU critically ill patients affected by nosocomial pneumonia, defined as: Out of ICU Hospital-acquired Pneumonia (HAP), Non-ventilator ICU-acquired Pneumonia (NV ICUAP), Ventilator associated pneumonia (VAP) Ventilator associated… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pneumonia
- How many people
- 600 participants
- Where
- 1 siteIreland
- Study dates
- 1 Sep 2016to 31 Dec 2018
- How long will I take part?
- 4 Weeks
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All ICU patients with a documented Nosocomial Lower Respiratory Tract Infection will be eligible for this epidemiological, clinical and microbiological investigation
Who may be able to join
- Age ≥ 18 years
- Diagnosis of nosocomial pneumonia
- ICU and HDU admission (patient may be admitted to the ICU with NP or may develop pneumonia during ICU stay)
- Informed consent (if required)
Who cannot join
- Community Acquired Infection
- Absence of Microbiological Findings
Trial locations and contacts
1 site in 1 country.
Ignacio Martin Loeches, MD contact
Ireland1 site, 1 recruiting
- Recruiting
St James's University Hospital
Dublin
Ignacio Martin Loeches, PhD JFICMI, drmartinloeches@gmail.com
About this study
Official title: Epidemiological, Microbiological and Clinical Profile of Ice Patients With Nosocomial Lower Respiratory Tract Infections
This is a multicentre, multinational, prospective observational investigation on ICU critically ill patients affected by nosocomial pneumonia, defined as: Out of ICU Hospital-acquired Pneumonia (HAP), Non-ventilator ICU-acquired Pneumonia (NV ICUAP), Ventilator associated pneumonia (VAP) Ventilator associated tracheobronchitis (VAT).
- Conditions
- Pneumonia
- Being tested
- No intervention
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No Interventions
| Study group | Role | What they receive |
|---|---|---|
| Cases | All ICU patients with nosocomial lower respiratory tract infection Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients dying among the different pneumonia categories
Measured: 28 days
Secondary outcomes (4)
Number of patients with different epidemiological patterns
Measured: 28 days
Number of patients with specific microbiological profiles
Measured: 28 days
Number of patients with specific clinical characteristics
Measured: 28 days
Number of patients with different therapeutically interventions
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start1 Sep 2016
- Primary completion1 Sep 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies 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
- 600 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183921
- Sponsor's protocol ID
- ENIRRIs 01
- Acronym
- ENIRRIs
- Status last verified
- Jun 2017
- First submitted
- 20 Apr 2017
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Serrano-Mayorga CC, Olivella-Gomez J, Sanabria-Herrera N, Nseir S, Torres A, Martin-Loeches I, Reyes LF; European Network for ICU-Related Respiratory Infections Study Group. Pseudomonas aeruginosa in Patients With Nosocomial Respiratory Infections: A Secondary Analysis of the European Network for ICU-Related Respiratory Infections. Chest. 2026 May;169(5):1240-1254. doi: 10.1016/j.chest.2025.12.033. Epub 2026 Jan 9.
PubMed 41520818Martin-Loeches I, Reyes LF, Nseir S, Ranzani O, Povoa P, Diaz E, Schultz MJ, Rodriguez AH, Serrano-Mayorga CC, De Pascale G, Navalesi P, Panigada M, Coelho LM, Skoczynski S, Esperatti M, Cortegiani A, Aliberti S, Caricato A, Salzer HJF, Ceccato A, Civljak R, Soave PM, Luyt CE, Ekren PK, Rios F, Masclans JR, Marin J, Iglesias-Moles S, Nava S, Chiumello D, Bos LD, Artigas A, Froes F, Grimaldi D, Taccone FS, Antonelli M, Torres A; European Network for ICU-Related Respiratory Infections (ENIRRIs) European Respiratory Society-Clinical Research Collaboration Investigators. European Network for ICU-Related Respiratory Infections (ENIRRIs): a multinational, prospective, cohort study of nosocomial LRTI. Intensive Care Med. 2023 Oct;49(10):1212-1222. doi: 10.1007/s00134-023-07210-9. Epub 2023 Oct 9.
PubMed 37812242
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological, Microbiological and Clinical Profile of Ice Patients With Nosocomial Lower Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT03183921
- Acronym / sponsor ID
- ENIRRIs / ENIRRIs 01
- Conditions
- Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 12 Jun 2017 (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.
This is a multicentre, multinational, prospective observational investigation on ICU critically ill patients affected by nosocomial pneumonia, defined as: Out of ICU Hospital-acquired Pneumonia (HAP), Non-ventilator ICU-acquired Pneumonia (NV ICUAP), Ventilator associated pneumonia (VAP) Ventilator associated tracheobronchitis (VAT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: No interventionAll ICU patients with nosocomial lower respiratory tract infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All ICU patients with a documented Nosocomial Lower Respiratory Tract Infection will be eligible for this epidemiological, clinical and microbiological investigation
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Diagnosis of nosocomial pneumonia
- ICU and HDU admission (patient may be admitted to the ICU with NP or may develop pneumonia during ICU stay)
- Informed consent (if required)
Key exclusion criteria (2 listed)
- Community Acquired Infection
- Absence of Microbiological Findings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo Interventions | Other | Cases |
Primary outcome
Number of patients dying among the different pneumonia categories
Time frame: 28 days
4 secondary outcomes
Number of patients with different epidemiological patterns
Time frame: 28 days
Number of patients with specific microbiological profiles
Time frame: 28 days
Number of patients with specific clinical characteristics
Time frame: 28 days
Number of patients with different therapeutically interventions
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Derived from this study: PubMed 41520818Serrano-Mayorga CC, Olivella-Gomez J, Sanabria-Herrera N, Nseir S, Torres A, Martin-Loeches I, Reyes LF; European Network for ICU-Related Respiratory Infections Study Group. Pseudomonas aeruginosa in Patients With Nosocomial Respiratory Infections: A Secondary Analysis of the European Network for ICU-Related Respiratory Infections. Chest. 2026 May;169(5):1240-1254. doi: 10.1016/j.chest.2025.12.033. Epub 2026 Jan 9.
- Derived from this study: PubMed 37812242Martin-Loeches I, Reyes LF, Nseir S, Ranzani O, Povoa P, Diaz E, Schultz MJ, Rodriguez AH, Serrano-Mayorga CC, De Pascale G, Navalesi P, Panigada M, Coelho LM, Skoczynski S, Esperatti M, Cortegiani A, Aliberti S, Caricato A, Salzer HJF, Ceccato A, Civljak R, Soave PM, Luyt CE, Ekren PK, Rios F, Masclans JR, Marin J, Iglesias-Moles S, Nava S, Chiumello D, Bos LD, Artigas A, Froes F, Grimaldi D, Taccone FS, Antonelli M, Torres A; European Network for ICU-Related Respiratory Infections (ENIRRIs) European Respiratory Society-Clinical Research Collaboration Investigators. European Network for ICU-Related Respiratory Infections (ENIRRIs): a multinational, prospective, cohort study of nosocomial LRTI. Intensive Care Med. 2023 Oct;49(10):1212-1222. doi: 10.1007/s00134-023-07210-9. Epub 2023 Oct 9.
- Individual participant dataSharing planned: Undecided
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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.
Ignacio Martin Loeches, MD contact
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 Pneumonia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Ireland.
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 4 inclusion and 2 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 12 Jun 2017. 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 Ireland. 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 Ignacio Martin Loeches, MD (drmartinloeches@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients dying among the different pneumonia categories (time frame: 28 days). 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 NCT03183921, which also lists 2 linked publications.
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 12 Jun 2017.