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

Completed

• Conditions: Pneumonia; Pneumonia, Ventilator-Associated; Nosocomial Pneumonia
• Interventions: Other: Various observed exposure(s) of interest

• Registration Number: NCT02413242
• Lead Sponsor: Jan Kluytmans

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-04-06
• Study First Posted: 2015-04-09
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2031

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU subjects, S. aureus+ at ICU admission	Various observed exposure(s) of interest	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	Various observed exposure(s) of interest	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.

Primary Outcome Measures

Name	Time	Method
Incidence of P. aeruginosa ICU pneumonia	date of ICF until ICU discharge (on average 7 days after ICF)
Incidence of S. aureus ICU pneumonia	date of ICF until ICU discharge (on average 7 days after ICF)

Secondary Outcome Measures

Name	Time	Method
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)
Time to all cause ICU pneumonia	day of ICU admission until ICU discharge (on average 7 days after ICU admission)
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)
Time to P. aeruginosa ICU pneumonia	day of ICU admission until ICU discharge (on average 7 days after ICU admission)
Incidence of S. aureus ICU pneumonia stratified by MRSA vs. MSSA	date of ICF until ICU discharge (on average 7 days after ICF)
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 all cause ICU bacteremia	day of ICU admission until ICU discharge (on average 7 days after ICU admission)
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)
Time to death of any cause	day of ICU admission until day 90 or ICU discharge, whichever comes first

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands