Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| MedImmune LLC | INDUSTRY |
| Universiteit Antwerpen | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Various observed exposure(s) of interest | Other | A risk prediction model will be developed to assess which risk factors are associated with the development of ICU pneumonia during ICU stay |
| 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) |
| 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) | |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jan A.J.W. Kluytmans, Prof. | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Utrecht | Utrecht | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37415223 | Derived | 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. | |
| 28946849 |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D053717 | Pneumonia, Ventilator-Associated |
| D000077299 | Healthcare-Associated Pneumonia |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Microbiological samples:
Blood samples * Blood samples will be taken at day of ICF, day 7 and day 30 or day of ICU discharge (whichever occurs first), day of ICU pneumonia, day 7 after ICU pneumonia and day 30 after ICU pneumonia.
| 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 |
| 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) |
| 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) |
| 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. |
| D003428 |
| Cross Infection |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |