Clinical trial NCT02413242: Advanced Understanding of Staphylococcus Aureus and Pseudomonas Aeruginosa Infections in EuRopE - ICU
Official title: Advanced Understanding of Staphylococcus Aureus and Pseudomonas Aeruginosa Infections in EuRopE - ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Pneumonia, Ventilator-Associated
Nosocomial Pneumonia
Keywords: S. aureus
P. aeruginosa
Colonization
Pneumonia
ICU
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: MedImmune LLC
name: Universiteit Antwerpen
First posted: 2015-04-09
Enrollment: 2031
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of S. aureus ICU pneumonia
timeFrame: date of ICF until ICU discharge (on average 7 days after ICF)
measure: Incidence of P. aeruginosa ICU pneumonia
timeFrame: date of ICF until ICU discharge (on average 7 days after ICF)
Secondary outcomes:
measure: Prevalence of S. aureus / P. aeruginosa colonization
timeFrame: at ICU admission
measure: Incidence of all cause ICU pneumonia
timeFrame: date of ICF until ICU discharge (on average 7 days after ICF)
measure: Incidence of S. aureus ICU pneumonia stratified by MRSA vs. MSSA
timeFrame: date of ICF until ICU discharge (on average 7 days after ICF)
measure: Incidence of P. aeruginosa ICU pneumonia stratified by MDR-PA vs. S-PA
timeFrame: date of ICF until ICU discharge (on average 7 days after ICF)
measure: Incidence of ICU bacteremia per etiologic agent (in case of S. aureus and/or P. aeruginosa and for all clinically relevant other pathogens)
timeFrame: date of ICF until ICU discharge (on average 7 days after ICF)
measure: All-cause mortality
timeFrame: date of ICF until ICU discharge (on average 7 days after ICF)
measure: All-cause mortality
timeFrame: At day 30 after ICU admission
measure: All-cause mortality
timeFrame: At day 90 after ICU admission
measure: Time to S. aureus ICU pneumonia
timeFrame: day of ICU admission until ICU discharge (on average 7 days after ICU admission)
measure: Time to P. aeruginosa ICU pneumonia
timeFrame: day of ICU admission until ICU discharge (on average 7 days after ICU admission)
measure: Time to all cause ICU pneumonia
timeFrame: day of ICU admission until ICU discharge (on average 7 days after ICU admission)
measure: Time to all cause ICU bacteremia
timeFrame: day of ICU admission until ICU discharge (on average 7 days after ICU admission)
measure: Time to death of any cause
timeFrame: day of ICU admission until day 90 or ICU discharge, whichever comes first
Other outcomes:
measure: Magnitude of healthcare utilization as measured by: a. Duration of ICU stay including readmissions
timeFrame: day of ICU admission until day 30 after ICU discharge
measure: Magnitude of healthcare utilization as measured by: b. Days on mechanical ventilation
timeFrame: day of ICU admission until ICU discharge (on average 9 days after ICU admission)
measure: Magnitude of healthcare utilization as measured by: c. Days of antibiotic usage
timeFrame: day of ICU admission until ICU discharge (on average 9 days after ICU admission)
measure: Magnitude of healthcare utilization as measured by: d. Duration of hospital stay, including readmissions
timeFrame: day of ICU admission until ICU discharge (on average 9 days after ICU admission)
measure: Incidence of S. aureus colonization
timeFrame: from day of ICU admission until onset of ICU pneumonia (on average 7 days after ICU admission)
measure: Incidence of P. aeruginosa colonization
timeFrame: from day of ICU admission until onset of ICU pneumonia (on average 7 days after ICU admission)
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Jan A.J.W. Kluytmans, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paling 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.