NCT03183921

Brief 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 tracheobronchitis (VAT).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

April 20, 2017

Last Update Submit

June 9, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients dying among the different pneumonia categories

    28 days

Secondary Outcomes (4)

  • Number of patients with different epidemiological patterns

    28 days

  • Number of patients with specific microbiological profiles

    28 days

  • Number of patients with specific clinical characteristics

    28 days

  • Number of patients with different therapeutically interventions

    28 days

Study Arms (1)

Cases

All ICU patients with nosocomial lower respiratory tract infection

Other: No intervention

Interventions

No Interventions

Cases

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All ICU patients with a documented Nosocomial Lower Respiratory Tract Infection will be eligible for this epidemiological, clinical and microbiological investigation

You may qualify if:

  • 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)

You may not qualify if:

  • Community Acquired Infection
  • Absence of Microbiological Findings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St James's University Hospital

Dublin, Ireland

RECRUITING

Related Publications (1)

  • Martin-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.

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Ignacio Martin Loeches, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2017

First Posted

June 12, 2017

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

December 31, 2018

Last Updated

June 12, 2017

Record last verified: 2017-06

Locations