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

Study Overview
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Brief Summary
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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.

Official Title
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Advanced Understanding of Staphylococcus Aureus and Pseudomonas Aeruginosa Infections in EuRopE - ICU

Conditions
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Pneumonia, Pneumonia, Ventilator-Associated, Nosocomial Pneumonia

Intervention / Treatment
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* Other: Various observed exposure(s) of interest


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU subjects, S. aureus+ at ICU admission<br>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<br>* A risk prediction model will be developed to assess which risk factors are associated with the development of ICU pneumonia during ICU stay<br>|
| ICU subjects, S. aureus- at ICU admission<br>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<br>* A risk prediction model will be developed to assess which risk factors are associated with the development of ICU pneumonia during ICU stay<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 S. aureus ICU pneumonia stratified by MRSA vs. MSSA |  | 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) | 
| 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) | 
| All-cause mortality |  | At day 30 after ICU admission | 
| All-cause mortality |  | At day 90 after ICU admission | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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S. aureus, P. aeruginosa, Colonization, Pneumonia, ICU