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OpenTrials
Completed

NCT Number: NCT02413242

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

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.

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Key information

Conditions

Pneumonia Bacterial Infections Bacterial Infections and Mycoses Cross Infection Disease Attributes Gram-Positive Bacterial Infections Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Nosocomial Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Staphylococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UMC Utrecht

Utrecht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Incidence of S. aureus ICU pneumonia

    Time frame: date of ICF until ICU discharge (on average 7 days after ICF)

  2. Incidence of P. aeruginosa ICU pneumonia

    Time frame: date of ICF until ICU discharge (on average 7 days after ICF)

Secondary outcomes

  1. Prevalence of S. aureus / P. aeruginosa colonization

    Time frame: at ICU admission

  2. Incidence of all cause ICU pneumonia

    Time frame: date of ICF until ICU discharge (on average 7 days after ICF)

  3. Incidence of S. aureus ICU pneumonia stratified by MRSA vs. MSSA

    Time frame: date of ICF until ICU discharge (on average 7 days after ICF)

  4. Incidence of P. aeruginosa ICU pneumonia stratified by MDR-PA vs. S-PA

    Time frame: date of ICF until ICU discharge (on average 7 days after ICF)

  5. Incidence of ICU bacteremia per etiologic agent (in case of S. aureus and/or P. aeruginosa and for all clinically relevant other pathogens)

    Time frame: date of ICF until ICU discharge (on average 7 days after ICF)

  6. All-cause mortality

    Time frame: date of ICF until ICU discharge (on average 7 days after ICF)

  7. All-cause mortality

    Time frame: At day 30 after ICU admission

  8. All-cause mortality

    Time frame: At day 90 after ICU admission

  9. Time to S. aureus ICU pneumonia

    Time frame: day of ICU admission until ICU discharge (on average 7 days after ICU admission)

  10. Time to P. aeruginosa ICU pneumonia

    Time frame: day of ICU admission until ICU discharge (on average 7 days after ICU admission)

  11. Time to all cause ICU pneumonia

    Time frame: day of ICU admission until ICU discharge (on average 7 days after ICU admission)

  12. Time to all cause ICU bacteremia

    Time frame: day of ICU admission until ICU discharge (on average 7 days after ICU admission)

  13. Time to death of any cause

    Time frame: day of ICU admission until day 90 or ICU discharge, whichever comes first

Other outcomes

  1. Magnitude of healthcare utilization as measured by: a. Duration of ICU stay including readmissions

    Time frame: day of ICU admission until day 30 after ICU discharge

  2. Magnitude of healthcare utilization as measured by: b. Days on mechanical ventilation

    Time frame: day of ICU admission until ICU discharge (on average 9 days after ICU admission)

  3. Magnitude of healthcare utilization as measured by: c. Days of antibiotic usage

    Time frame: day of ICU admission until ICU discharge (on average 9 days after ICU admission)

  4. Magnitude of healthcare utilization as measured by: d. Duration of hospital stay, including readmissions

    Time frame: day of ICU admission until ICU discharge (on average 9 days after ICU admission)

  5. Incidence of S. aureus colonization

    Time frame: from day of ICU admission until onset of ICU pneumonia (on average 7 days after ICU admission)

  6. Incidence of P. aeruginosa colonization

    Time frame: from day of ICU admission until onset of ICU pneumonia (on average 7 days after ICU admission)

Sponsors and collaborators

Lead sponsor

Jan Kluytmans

Other

Collaborators

  • MedImmune LLC
  • Universiteit Antwerpen

Registry information

Acronym: ASPIRE-ICU

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 9, 2015
Registry last updated
May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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