PneumoniaASPIRE-ICUNCT02413242
Advanced Understanding of Staphylococcus Aureus and Pseudomonas Aeruginosa Infections in EuRopE - ICU
An observational study of Pneumonia and Pneumonia, Ventilator-Associated, run by Jan Kluytmans at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Pneumonia, Ventilator-Associated, Nosocomial Pneumonia
- What is being tested?
- Various observed exposure(s) of interest
- How many people
- 2,031 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2015to 30 Apr 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Participant is 18 years or older at the time of enrollment.
- Participant is on mechanical ventilation at ICU admission, or is (expected to be) within 24 hours thereafter, based on investigator's judgment.
- Expected stay in ICU is 48 hours or longer based on investigator's judgment.
- 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.
- Written informed consent from subject / legally accepted representative within 72 hours after start of first episode of mechanical ventilation.
Who cannot join
- Previous participation as a subject in the study cohort of this study.
- Simultaneous participation of the subject in any preventive experimental study into anti-staphylococcus or anti-pseudomonas aeruginosa interventions.
- Expected death (moribund status) within 48h, or ICU discharge of the participant within 24h, at the moment of informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Various observed exposure(s) of interest
- Keywords
- S. aureus, P. aeruginosa, Colonization, Pneumonia, ICU
- Medical subject headings
- Pneumonia, Pneumonia, Ventilator-Associated, Healthcare-Associated Pneumonia, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Various observed exposure(s) of interestOther
A risk prediction model will be developed to assess which risk factors are associated with the development of ICU pneumonia during ICU stay
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Various observed exposure(s) of interest | |
| 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. Receives: Other: Various observed exposure(s) of interest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of S. aureus ICU pneumonia
Measured: date of ICF until ICU discharge (on average 7 days after ICF)
Incidence of P. aeruginosa ICU pneumonia
Measured: date of ICF until ICU discharge (on average 7 days after ICF)
Secondary outcomes (13)
Prevalence of S. aureus / P. aeruginosa colonization
Measured: at ICU admission
Incidence of all cause ICU pneumonia
Measured: date of ICF until ICU discharge (on average 7 days after ICF)
Incidence of S. aureus ICU pneumonia stratified by MRSA vs. MSSA
Measured: 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
Measured: 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)
Measured: date of ICF until ICU discharge (on average 7 days after ICF)
All-cause mortality
Measured: date of ICF until ICU discharge (on average 7 days after ICF)
All-cause mortality
Measured: At day 30 after ICU admission
All-cause mortality
Measured: At day 90 after ICU admission
Time to S. aureus ICU pneumonia
Measured: day of ICU admission until ICU discharge (on average 7 days after ICU admission)
Time to P. aeruginosa ICU pneumonia
Measured: day of ICU admission until ICU discharge (on average 7 days after ICU admission)
Time to all cause ICU pneumonia
Measured: day of ICU admission until ICU discharge (on average 7 days after ICU admission)
Time to all cause ICU bacteremia
Measured: day of ICU admission until ICU discharge (on average 7 days after ICU admission)
Time to death of any cause
Measured: day of ICU admission until day 90 or ICU discharge, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startApr 2015
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
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.
- 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
- 2,031 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan Kluytmans
- Sponsor type
- University, hospital or other
- Collaborators
- MedImmune LLC, Universiteit Antwerpen
- Responsible party
- Sponsor-investigator, Jan Kluytmans, UMC Utrecht
- Investigators
- Jan A.J.W. Kluytmans, Prof., Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413242
- Sponsor's protocol ID
- NL51762.041.14
- Acronym
- ASPIRE-ICU
- Status last verified
- May 2019
- First submitted
- 1 Apr 2015
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
van Engelen TSR, Reijnders TDY, Paling FP, Bonten MJM, Timbermont L, Malhotra-Kumar S, Kluytmans JAJW, Peters-Sengers H, van der Poll T; ASPIRE-I. C. U. Study Team. Plasma protein biomarkers reflective of the host response in patients developing Intensive Care Unit-acquired pneumonia. Crit Care. 2023 Jul 6;27(1):269. doi: 10.1186/s13054-023-04536-0.
PubMed 37415223Paling FP, Troeman DPR, Wolkewitz M, Kalyani R, Prins DR, Weber S, Lammens C, Timbermont L, Goossens H, Malhotra-Kumar S, Sifakis F, Bonten MJM, Kluytmans JAJW. Rationale and design of ASPIRE-ICU: a prospective cohort study on the incidence and predictors of Staphylococcus aureus and Pseudomonas aeruginosa pneumonia in the ICU. BMC Infect Dis. 2017 Sep 25;17(1):643. doi: 10.1186/s12879-017-2739-4.
PubMed 28946849
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Understanding of Staphylococcus Aureus and Pseudomonas Aeruginosa Infections in EuRopE - ICU
- ClinicalTrials.gov ID
- NCT02413242
- Acronym / sponsor ID
- ASPIRE-ICU / NL51762.041.14
- Keywords
- S. aureus, P. aeruginosa, Colonization, Pneumonia, ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,031 participants (actual)
- Lead sponsor
- Jan KluytmansUniversity, hospital or other
- Collaborators
- MedImmune LLC, Universiteit Antwerpen
- Study start
- Apr 2015 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 9 Apr 2015 (estimated)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU subjects, S. aureus+ at ICU admission | – | Other: Various observed exposure(s) of interestAdult 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. |
| ICU subjects, S. aureus- at ICU admission | – | Other: Various observed exposure(s) of interestAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Participant is 18 years or older at the time of enrollment.
- Participant is on mechanical ventilation at ICU admission, or is (expected to be) within 24 hours thereafter, based on investigator's judgment.
- Expected stay in ICU is 48 hours or longer based on investigator's judgment.
- 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.
- Written informed consent from subject / legally accepted representative within 72 hours after start of first episode of mechanical ventilation.
Key exclusion criteria (3 listed)
- Previous participation as a subject in the study cohort of this study.
- Simultaneous participation of the subject in any preventive experimental study into anti-staphylococcus or anti-pseudomonas aeruginosa interventions.
- Expected death (moribund status) within 48h, or ICU discharge of the participant within 24h, at the moment of informed consent.
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 |
|---|---|---|
| Various observed exposure(s) of interestA risk prediction model will be developed to assess which risk factors are associated with the development of ICU pneumonia during ICU stay | Other | ICU subjects, S. aureus+ at ICU admission, ICU subjects, S. aureus- at ICU admission |
Primary outcome
Incidence of S. aureus ICU pneumonia
Time frame: 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)
13 secondary outcomes
Prevalence of S. aureus / P. aeruginosa colonization
Time frame: at ICU admission
Incidence of all cause ICU pneumonia
Time frame: 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)
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)
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)
All-cause mortality
Time frame: date of ICF until ICU discharge (on average 7 days after ICF)
All-cause mortality
Time frame: At day 30 after ICU admission
All-cause mortality
Time frame: 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)
Time to P. aeruginosa ICU pneumonia
Time frame: 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)
Time to all cause ICU bacteremia
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
- Derived from this study: PubMed 37415223van Engelen TSR, Reijnders TDY, Paling FP, Bonten MJM, Timbermont L, Malhotra-Kumar S, Kluytmans JAJW, Peters-Sengers H, van der Poll T; ASPIRE-I. C. U. Study Team. Plasma protein biomarkers reflective of the host response in patients developing Intensive Care Unit-acquired pneumonia. Crit Care. 2023 Jul 6;27(1):269. doi: 10.1186/s13054-023-04536-0.
- Derived from this study: PubMed 28946849Paling FP, Troeman DPR, Wolkewitz M, Kalyani R, Prins DR, Weber S, Lammens C, Timbermont L, Goossens H, Malhotra-Kumar S, Sifakis F, Bonten MJM, Kluytmans JAJW. Rationale and design of ASPIRE-ICU: a prospective cohort study on the incidence and predictors of Staphylococcus aureus and Pseudomonas aeruginosa pneumonia in the ICU. BMC Infect Dis. 2017 Sep 25;17(1):643. doi: 10.1186/s12879-017-2739-4.
- Related InfoLink provided by the sponsor.
- 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.
Jan A.J.W. Kluytmans, Prof. principal investigator
UMC Utrecht
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 and Pneumonia, Ventilator-Associated, run by Jan Kluytmans at 1 site in Netherlands.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 8 May 2019. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of S. aureus ICU pneumonia (time frame: date of ICF until ICU discharge (on average 7 days after ICF)). The study lists 2 primary outcomes in all. 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 NCT02413242, 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 8 May 2019.