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

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ClinicalTrials.gov Identifier: NCT02413242
Recruitment Status : Completed
First Posted : April 9, 2015
Last Update Posted : May 8, 2019
Sponsor:
Collaborators:
MedImmune LLC
Universiteit Antwerpen
Information provided by (Responsible Party):
Jan Kluytmans, UMC Utrecht

Tracking Information
First Submitted Date April 1, 2015
First Posted Date April 9, 2015
Last Update Posted Date May 8, 2019
Actual Study Start Date April 2015
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 6, 2015)
  • Incidence of S. aureus ICU pneumonia [ Time Frame: date of ICF until ICU discharge (on average 7 days after ICF) ]
  • Incidence of P. aeruginosa ICU pneumonia [ Time Frame: date of ICF until ICU discharge (on average 7 days after ICF) ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 17, 2016)
  • Prevalence of S. aureus / P. aeruginosa colonization [ Time Frame: at ICU admission ]
  • Incidence of all cause ICU pneumonia [ Time Frame: date of ICF until ICU discharge (on average 7 days after ICF) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • All-cause mortality [ Time Frame: date of ICF until ICU discharge (on average 7 days after ICF) ]
  • All-cause mortality [ Time Frame: At day 30 after ICU admission ]
  • All-cause mortality [ Time Frame: At day 90 after ICU admission ]
  • Time to S. aureus ICU pneumonia [ Time Frame: day of ICU admission until ICU discharge (on average 7 days after ICU admission) ]
  • Time to P. aeruginosa ICU pneumonia [ Time Frame: day of ICU admission until ICU discharge (on average 7 days after ICU admission) ]
  • Time to all cause ICU pneumonia [ Time Frame: day of ICU admission until ICU discharge (on average 7 days after ICU admission) ]
  • Time to all cause ICU bacteremia [ Time Frame: day of ICU admission until ICU discharge (on average 7 days after ICU admission) ]
  • Time to death of any cause [ Time Frame: day of ICU admission until day 90 or ICU discharge, whichever comes first ]
Original Secondary Outcome Measures
 (submitted: April 6, 2015)
  • Prevalence of S. aureus / P. aeruginosa ETA colonization [ Time Frame: at ICU admission ]
  • Incidence of all cause ICU pneumonia [ Time Frame: date of ICF until ICU discharge (on average 7 days after ICF) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • All-cause mortality [ Time Frame: date of ICF until ICU discharge (on average 7 days after ICF) ]
  • All-cause mortality [ Time Frame: At day 30 after ICU admission ]
  • All-cause mortality [ Time Frame: At day 90 after ICU admission ]
  • Time to S. aureus ICU pneumonia [ Time Frame: day of ICU admission until ICU discharge (on average 7 days after ICU admission) ]
  • Time to P. aeruginosa ICU pneumonia [ Time Frame: day of ICU admission until ICU discharge (on average 7 days after ICU admission) ]
  • Time to all cause ICU pneumonia [ Time Frame: day of ICU admission until ICU discharge (on average 7 days after ICU admission) ]
  • Time to all cause ICU bacteremia [ Time Frame: day of ICU admission until ICU discharge (on average 7 days after ICU admission) ]
  • Time to death of any cause [ Time Frame: day of ICU admission until day 90 or ICU discharge, whichever comes first ]
Current Other Pre-specified Outcome Measures
 (submitted: April 6, 2015)
  • 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 ]
  • 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) ]
  • 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) ]
  • 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) ]
  • Incidence of S. aureus colonization [ Time Frame: from day of ICU admission until onset of ICU pneumonia (on average 7 days after ICU admission) ]
  • Incidence of P. aeruginosa colonization [ Time Frame: from day of ICU admission until onset of ICU pneumonia (on average 7 days after ICU admission) ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Advanced Understanding of Staphylococcus Aureus and Pseudomonas Aeruginosa Infections in EuRopE - ICU
Official Title Advanced Understanding of Staphylococcus Aureus and Pseudomonas Aeruginosa Infections in EuRopE - ICU
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:

  • Microbiological samples:

    • Nose swabs - at day of informed consent form (ICF), day 4, day 7.
    • Peri-anal swabs - at day of ICF, day 4, day 7, then twice weekly until day 30.
    • Lower respiratory tract (LRT) sample - at day of ICF, day 4, day 7, then twice weekly until day 30, day of ICU pneumonia, day 7 after ICU pneumonia. The LRT sample can be defined as the collection of an endotracheal aspirate (ETA). If an ETA cannot be collected, a sputum sample may be taken.
    • Broncho alveolar lavage - If available through clinical procedures, BAL specimens will be collected for study purposes.
  • 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.
Sampling Method Probability Sample
Study Population

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.
Condition
  • Pneumonia
  • Pneumonia, Ventilator-Associated
  • Nosocomial Pneumonia
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
Study Groups/Cohorts
  • 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.

    Intervention: Other: Various observed exposure(s) of interest
  • 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.

    Intervention: Other: Various observed exposure(s) of interest
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 6, 2019)		 2031
Original Estimated Enrollment
 (submitted: April 6, 2015)		 2000
Actual Study Completion Date April 30, 2019
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02413242
Other Study ID Numbers NL51762.041.14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Jan Kluytmans, UMC Utrecht
Original Responsible Party Same as current
Current Study Sponsor Jan Kluytmans
Original Study Sponsor Same as current
Collaborators
  • MedImmune LLC
  • Universiteit Antwerpen
Investigators
Principal Investigator: Jan A.J.W. Kluytmans, Prof. UMC Utrecht
PRS Account UMC Utrecht
Verification Date May 2019