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

Pneumonia Clinical Trial

— ASPIRE-ICU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413242
• Other study ID #: NL51762.041.14
• Status: Completed
• Start date: April 2015
• Est. completion date: April 30, 2019

Study information

• Verified date: May 2019
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2031
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthcare-Associated Pneumonia
• Nosocomial Pneumonia
• Pneumonia
• Pneumonia, Ventilator-Associated
• Pseudomonas Infections

Intervention

Other:
• Various 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

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
Jan Kluytmans	MedImmune LLC, Universiteit Antwerpen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Magnitude of healthcare utilization as measured by: a. Duration of ICU stay including readmissions		day of ICU admission until day 30 after ICU discharge
Other	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)
Other	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)
Other	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)
Other	Incidence of S. aureus colonization		from day of ICU admission until onset of ICU pneumonia (on average 7 days after ICU admission)
Other	Incidence of P. aeruginosa colonization		from day of ICU admission until onset of ICU pneumonia (on average 7 days after ICU admission)
Primary	Incidence of S. aureus ICU pneumonia		date of ICF until ICU discharge (on average 7 days after ICF)
Primary	Incidence of P. aeruginosa ICU pneumonia		date of ICF until ICU discharge (on average 7 days after ICF)
Secondary	Prevalence of S. aureus / P. aeruginosa colonization		at ICU admission
Secondary	Incidence of all cause ICU pneumonia		date of ICF until ICU discharge (on average 7 days after ICF)
Secondary	Incidence of S. aureus ICU pneumonia stratified by MRSA vs. MSSA		date of ICF until ICU discharge (on average 7 days after ICF)
Secondary	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)
Secondary	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)
Secondary	All-cause mortality		date of ICF until ICU discharge (on average 7 days after ICF)
Secondary	All-cause mortality		At day 30 after ICU admission
Secondary	All-cause mortality		At day 90 after ICU admission
Secondary	Time to S. aureus ICU pneumonia		day of ICU admission until ICU discharge (on average 7 days after ICU admission)
Secondary	Time to P. aeruginosa ICU pneumonia		day of ICU admission until ICU discharge (on average 7 days after ICU admission)
Secondary	Time to all cause ICU pneumonia		day of ICU admission until ICU discharge (on average 7 days after ICU admission)
Secondary	Time to all cause ICU bacteremia		day of ICU admission until ICU discharge (on average 7 days after ICU admission)
Secondary	Time to death of any cause		day of ICU admission until day 90 or ICU discharge, whichever comes first

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