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NCT03183921 Clinical Trial

Study on ICU Patients With Nosocomial Lower Respiratory Tract Infections

Pneumonia Clinical Trial

— ENIRRIs  

Official title:
Epidemiological, Microbiological and Clinical Profile of Ice Patients With Nosocomial Lower Respiratory Tract Infections

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03183921
Other study ID # ENIRRIs 01
Secondary ID
Status Recruiting
Phase N/A
First received April 20, 2017
Last updated June 9, 2017
Start date September 1, 2016
Est. completion date December 31, 2018

Study information
Verified date June 2017
Source Policlinico Universitario Agostino Gemelli
Contact Ignacio Martin Loeches, MD
Email drmartinloeches@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 tracheobronchitis (VAT).

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date December 31, 2018
Est. primary completion date September 1, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- Community Acquired Infection

- Absence of Microbiological Findings

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No Interventions

Locations
Country Name City State
Ireland St James's University Hospital Dublin

Sponsors (1)
Lead Sponsor Collaborator
Policlinico Universitario Agostino Gemelli

Country where clinical trial is conducted

Ireland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients dying among the different pneumonia categories 28 days
Secondary Number of patients with different epidemiological patterns 28 days
Secondary Number of patients with specific microbiological profiles 28 days
Secondary Number of patients with specific clinical characteristics 28 days
Secondary Number of patients with different therapeutically interventions 28 days
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