Nosocomial Pneumonia, Pneumonia, Pneumonia, Ventilator-Associated
Conditions
Keywords
S. aureus, P. aeruginosa, Colonization, Pneumonia, ICU
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.
Interventions
OTHERVarious 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
Sponsors
MedImmune LLC
Universiteit Antwerpen
Jan Kluytmans
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of S. aureus ICU pneumonia | date of ICF until ICU discharge (on average 7 days after ICF) |
| Incidence of P. aeruginosa ICU pneumonia | date of ICF until ICU discharge (on average 7 days after ICF) |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of S. aureus ICU pneumonia stratified by MRSA vs. MSSA | 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) | date of ICF until ICU discharge (on average 7 days after ICF) |
| All-cause mortality | date of ICF until ICU discharge (on average 7 days after ICF) |
| Time to S. aureus ICU pneumonia | day of ICU admission until ICU discharge (on average 7 days after ICU admission) |
| Time to P. aeruginosa ICU pneumonia | day of ICU admission until ICU discharge (on average 7 days after ICU admission) |
| Time to all cause ICU pneumonia | day of ICU admission until ICU discharge (on average 7 days after ICU admission) |
| Time to all cause ICU bacteremia | day of ICU admission until ICU discharge (on average 7 days after ICU admission) |
| Time to death of any cause | day of ICU admission until day 90 or ICU discharge, whichever comes first |
| Prevalence of S. aureus / P. aeruginosa colonization | at ICU admission |
| Incidence of all cause ICU pneumonia | 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 | date of ICF until ICU discharge (on average 7 days after ICF) |
Other
| Measure | Time frame |
|---|---|
| Magnitude of healthcare utilization as measured by: d. Duration of hospital stay, including readmissions | day of ICU admission until ICU discharge (on average 9 days after ICU admission) |
| Incidence of S. aureus colonization | from day of ICU admission until onset of ICU pneumonia (on average 7 days after ICU admission) |
| Incidence of P. aeruginosa colonization | from day of ICU admission until onset of ICU pneumonia (on average 7 days after ICU admission) |
| Magnitude of healthcare utilization as measured by: a. Duration of ICU stay including readmissions | day of ICU admission until day 30 after ICU discharge |
| Magnitude of healthcare utilization as measured by: b. Days on mechanical ventilation | 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 | day of ICU admission until ICU discharge (on average 9 days after ICU admission) |
Countries
Netherlands
Outcome results
None listed