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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jan Kluytmans

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
MedImmune LLC
Universiteit Antwerpen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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