Advanced Understanding of Staphylococcus Aureus and Pseudomonas Aeruginosa Infections in EuRopE - ICU (ASPIRE-ICU)

May 6, 2019 updated by: Jan Kluytmans
Intensive Care Unit (ICU) acquired pneumonia, including ventilator-associated pneumonia, is a frequently occurring health-care associated infection, which causes considerable morbidity, mortality and health care costs. Important pathogens causing ICU pneumonia are Staphylococcus aureus and Pseudomonas aeruginosa. The epidemiology of ICU pneumonia and patient-related and contextual factors is not fully described, but is urgently needed to support the development of effective interventions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2031

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ICU patients in approximately 30 sites in 6-12 European countries will be selected based on eligibility criteria that are described below.

Inclusion will be based on S. aureus (SA) colonization status at ICU admission (ratio 1:1). These subjects will be followed through their ICU stay for assessment of the primary outcomes.

Description

Inclusion Criteria:

  1. Participant is 18 years or older at the time of enrollment.
  2. Participant is on mechanical ventilation at ICU admission, or is (expected to be) within 24 hours thereafter, based on investigator's judgment.
  3. Expected stay in ICU is 48 hours or longer based on investigator's judgment.
  4. SA colonization status is known within 72 hours after start of first episode of mechanical ventilation and according to the result, the patient qualifies for enrollment.
  5. Written informed consent from subject / legally accepted representative within 72 hours after start of first episode of mechanical ventilation.

Exclusion Criteria:

  1. Previous participation as a subject in the study cohort of this study.
  2. Simultaneous participation of the subject in any preventive experimental study into anti-staphylococcus or anti-pseudomonas aeruginosa interventions.
  3. Expected death (moribund status) within 48h, or ICU discharge of the participant within 24h, at the moment of informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ICU subjects, S. aureus+ at ICU admission

Adult ICU patients, with a positive colonization status for S. aureus at ICU admission, who are mechanically ventilated within 24 hours of ICU admission and have an expected length of stay of 48h or more.

Colonization status will be measured at ICU admission using a nose swab and an ETA (or sputum/throat if unavailable). Positivity of either of the two qualifies the patient to be enrolled as a subject in this group.
Other: Various observed exposure(s) of interest
A risk prediction model will be developed to assess which risk factors are associated with the development of ICU pneumonia during ICU stay
ICU subjects, S. aureus- at ICU admission

Adult ICU patients, with a negative colonization status for S. aureus at ICU admission, who are mechanically ventilated within 24 hours of ICU admission and have an expected length of stay of 48h or more.

Colonization status will be measured at ICU admission using a nose swab and an ETA (or sputum/throat if unavailable). Negativity of both qualifies the patient to be enrolled as a subject in this group.
Other: Various observed exposure(s) of interest
A risk prediction model will be developed to assess which risk factors are associated with the development of ICU pneumonia during ICU stay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of S. aureus ICU pneumonia
Time Frame: date of ICF until ICU discharge (on average 7 days after ICF)
date of ICF until ICU discharge (on average 7 days after ICF)
Incidence of P. aeruginosa ICU pneumonia
Time Frame: date of ICF until ICU discharge (on average 7 days after ICF)
date of ICF until ICU discharge (on average 7 days after ICF)

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of S. aureus / P. aeruginosa colonization
Time Frame: at ICU admission
at ICU admission
Incidence of all cause ICU pneumonia
Time Frame: date of ICF until ICU discharge (on average 7 days after ICF)
date of ICF until ICU discharge (on average 7 days after ICF)
Incidence of S. aureus ICU pneumonia stratified by MRSA vs. MSSA
Time Frame: date of ICF until ICU discharge (on average 7 days after ICF)
date of ICF until ICU discharge (on average 7 days after ICF)
Incidence of P. aeruginosa ICU pneumonia stratified by MDR-PA vs. S-PA
Time Frame: date of ICF until ICU discharge (on average 7 days after ICF)
date of ICF until ICU discharge (on average 7 days after ICF)
Incidence of ICU bacteremia per etiologic agent (in case of S. aureus and/or P. aeruginosa and for all clinically relevant other pathogens)
Time Frame: date of ICF until ICU discharge (on average 7 days after ICF)
date of ICF until ICU discharge (on average 7 days after ICF)
All-cause mortality
Time Frame: date of ICF until ICU discharge (on average 7 days after ICF)
date of ICF until ICU discharge (on average 7 days after ICF)
All-cause mortality
Time Frame: At day 30 after ICU admission
At day 30 after ICU admission
All-cause mortality
Time Frame: At day 90 after ICU admission
At day 90 after ICU admission
Time to S. aureus ICU pneumonia
Time Frame: day of ICU admission until ICU discharge (on average 7 days after ICU admission)
day of ICU admission until ICU discharge (on average 7 days after ICU admission)
Time to P. aeruginosa ICU pneumonia
Time Frame: day of ICU admission until ICU discharge (on average 7 days after ICU admission)
day of ICU admission until ICU discharge (on average 7 days after ICU admission)
Time to all cause ICU pneumonia
Time Frame: day of ICU admission until ICU discharge (on average 7 days after ICU admission)
day of ICU admission until ICU discharge (on average 7 days after ICU admission)
Time to all cause ICU bacteremia
Time Frame: day of ICU admission until ICU discharge (on average 7 days after ICU admission)
day of ICU admission until ICU discharge (on average 7 days after ICU admission)
Time to death of any cause
Time Frame: day of ICU admission until day 90 or ICU discharge, whichever comes first
day of ICU admission until day 90 or ICU discharge, whichever comes first

Other Outcome Measures

Outcome Measure
Time Frame
Magnitude of healthcare utilization as measured by: a. Duration of ICU stay including readmissions
Time Frame: day of ICU admission until day 30 after ICU discharge
day of ICU admission until day 30 after ICU discharge
Magnitude of healthcare utilization as measured by: b. Days on mechanical ventilation
Time Frame: day of ICU admission until ICU discharge (on average 9 days after ICU admission)
day of ICU admission until ICU discharge (on average 9 days after ICU admission)
Magnitude of healthcare utilization as measured by: c. Days of antibiotic usage
Time Frame: day of ICU admission until ICU discharge (on average 9 days after ICU admission)
day of ICU admission until ICU discharge (on average 9 days after ICU admission)
Magnitude of healthcare utilization as measured by: d. Duration of hospital stay, including readmissions
Time Frame: day of ICU admission until ICU discharge (on average 9 days after ICU admission)
day of ICU admission until ICU discharge (on average 9 days after ICU admission)
Incidence of S. aureus colonization
Time Frame: from day of ICU admission until onset of ICU pneumonia (on average 7 days after ICU admission)
from day of ICU admission until onset of ICU pneumonia (on average 7 days after ICU admission)
Incidence of P. aeruginosa colonization
Time Frame: from day of ICU admission until onset of ICU pneumonia (on average 7 days after ICU admission)
from day of ICU admission until onset of ICU pneumonia (on average 7 days after ICU admission)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jan Kluytmans

Collaborators

MedImmune LLC
Universiteit Antwerpen

Investigators

  • Principal Investigator: Jan A.J.W. Kluytmans, Prof., UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

April 1, 2015

First Submitted That Met QC Criteria

April 6, 2015

First Posted (Estimate)

April 9, 2015

Study Record Updates

Last Update Posted (Actual)

May 8, 2019

Last Update Submitted That Met QC Criteria

May 6, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL51762.041.14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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