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

Jan Kluytmans

Status: Completed

Conditions: Pneumonia, Ventilator-Associated; Nosocomial Pneumonia; Pneumonia

Treatments: Other: Various observed exposure(s) of interest

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02413242

NL51762.041.14

Details and patient eligibility

About

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.

Enrollment: 2,031 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,031 participants in 2 patient groups

ICU subjects, S. aureus+ at ICU admission

Description:

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.

Treatment:

Other: Various observed exposure(s) of interest

ICU subjects, S. aureus- at ICU admission

Description:

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.

Treatment:

Other: Various observed exposure(s) of interest